TRICLIP DELIVERY SYSTEM (TCDS)

Report

• Report Number: 2135147-2025-06241
• Event Type: Injury
• Date Received: October 30, 2025
• Date of Event: April 17, 2024
• Report Date: October 30, 2025
• Manufacturer: ABBOTT MEDICAL
• Product Code: NPS
• PMA / PMN Number: P230007
• Report Source: Manufacturer report
• Reporter Location: US
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT IS FOR QUARTER 3 TIMEFRAME BETWEEN 01 JULY 2025 - 30 SEPTEMBER 2025. 475 ADVERSE EVENTS THAT COULD BE RELATED TO THE TRICLIP DEVICE WERE REPORTED INCLUDING ATRIAL FIBRILLATION, BLEEDING - ACCESS SITE, BLEEDING - HEMATOMA AT ACCESS SITE, BLEEDING - LIFE THREATENING, BLEEDING - MAJOR, BLEEDING - OTHER, BLEEDING - RETROPERITONEAL, CARDIAC ARREST, CARDIAC SURGERY OR INTERVENTION - OTHER UNPLANNED, COMPLETE LEAFLET CLIP DETACHMENT, DEEP VEIN THROMBOSIS, DEVICE EMBOLIZATION, DIALYSIS (NEW REQUIREMENT), ICD, MECHANICAL SUPPORT, MYOCARDIAL INFARCTION, PCI, PERMANENT PACEMAKER, READMISSION - HEART FAILURE, READMISSION (VALVE RELATED), RECURRENT TRICUSPID REGURGITATION, REINTERVENTION - TRICUSPID VALVE, STROKE - ISCHEMIC, VASCULAR COMPLICATION - MAJOR, VASCULAR COMPLICATION - MINOR, VASCULAR SURGERY OR INTERVENTION - UNPLANNED, WORSENING TRICUSPID REGURGITATION, UNKNOWN ADVERSE EVENT. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS LIMITED INFORMATION WAS PROVIDED INCLUDING THAT THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LIMITED INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, RISK ASSESSMENT WAS COMPLETED FOR THE REPORTED INCIDENTS. THE DEATH EVENTS AND RATES REPORTED IN THIS STUDY WERE FOUND TO BE ANTICIPATED IN THE STUDY POPULATION AND ARE IN ALIGNMENT WITH RATES OBSERVED IN OTHER CLINICAL STUDIES. NO NEW RISKS HAVE BEEN IDENTIFIED FOR THIS POPULATION. NO NEW HAZARDS OR HARMS WERE IDENTIFIED THAT WOULD IMPACT THE BENEFIT/RISK PROFILE. BASED ON A REVIEW OF THE AVAILABLE INFORMATION, THERE WAS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. THEREFORE, NO REMEDIAL ACTION IS REQUIRED AT THIS TIME. B3 - DATE OF EVENT USED IS THE EARLIEST EVENT DATE. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;9841923,4/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 04/02/2024 in a 84 year old Male. On 04/17/2024, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Major could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,80.7,4/2/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9841923,4/29/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 04/02/2024 in a 84 year old Male. On 04/29/2024, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Surgery or Intervention - Unplanned could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 1641 (0.8%) of subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,80.7,4/2/2024,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;8020318,5/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/02/2024 in a 84 year old Female. On 05/03/2024, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,65.3,5/2/2024,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;9743682,5/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 04/04/2024 in a 73 year old Female. On 05/06/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Female,124.7,4/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9743699,5/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 04/04/2024 in a 68 year old Female. On 05/06/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,68,Female,82.6,4/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9748240,5/22/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 04/26/2024 in a 71 year old Female. On 05/22/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,71,Female,78.6,4/26/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9939084,6/24/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/31/2024 in a 86 year old Male. On 06/24/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,80.6,5/31/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9750849,6/25/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/21/2024 in a 80 year old Male. On 06/25/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,72.1,5/21/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;6271722,7/8/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 06/11/2024 in a 83 year old Female. On 07/08/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,50.8,6/11/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9841309,7/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 06/07/2024 in a 90 year old Female. On 07/12/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Female,109.8,6/7/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;203533,7/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 06/26/2024 in a 87 year old Female. On 07/16/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,72.7,6/26/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9895806,7/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 06/12/2024 in a 88 year old Male. On 07/16/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Male,64.4,6/12/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8488455,8/7/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/01/2024 in a 82 year old Male. On 08/07/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,89.4,7/1/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;9899245,8/15/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/12/2024 in a 84 year old Male. On 08/15/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,83.9,7/12/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9893150,8/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/01/2024 in a 79 year old Female. On 08/16/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,62,7/1/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8409260,8/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/24/2024 in a 89 year old Female. On 08/20/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,68.9,7/24/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9141503,9/2/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 06/04/2024 in a 66 year old Female. On 09/02/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Female,73.9,6/4/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9941329,9/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 80 year old Male. On 09/03/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,93.2,8/14/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9941329,9/5/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 80 year old Male. On 09/05/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,93.2,8/14/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;9589509,9/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/07/2024 in a 84 year old Female. On 09/09/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,46.1,8/7/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;5707633,9/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/10/2024 in a 88 year old Male. On 09/14/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Male,91.2,9/10/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;7956707,9/15/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/09/2024 in a 85 year old Female. On 09/15/2024, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Dialysis (New Requirement) could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Dialysis (New Requirement) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,69.4,9/9/2024,NI,2041,4614,2993,4755,4114;4119,3221,4315,NA,0;9589709,9/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 82 year old Female. On 09/20/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,55.3,8/14/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9589721,9/25/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/23/2024 in a 76 year old Male. On 09/25/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,94.7,8/23/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9473090,9/25/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/26/2024 in a 84 year old Male. On 09/25/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,70.6,7/26/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;9419847,9/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/21/2024 in a 63 year old Female. On 09/26/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,63,Female,100.2,8/21/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9945280,9/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/16/2024 in a 80 year old Male. On 09/26/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,100.7,8/16/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9476984,9/28/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/25/2024 in a 62 year old Female. On 09/28/2024, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,62,Female,99.8,9/25/2024,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;9476984,9/28/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/25/2024 in a 62 year old Female. On 09/28/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,62,Female,99.8,9/25/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;8627252,9/29/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/27/2024 in a 87 year old Female. On 09/29/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,73.03,9/27/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;9941329,9/29/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 80 year old Male. On 09/29/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,93.2,8/14/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9941329,10/1/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 80 year old Male. On 10/01/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,93.2,8/14/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;9741547,10/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/03/2024 in a 66 year old Female. On 10/03/2024, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Arrest could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 1641 (0.3%) of subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Female,100.6,10/3/2024,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;9741547,10/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/03/2024 in a 66 year old Female. On 10/03/2024, Mechanical Support was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Mechanical Support could not be determined based on the limited data received from the registry.","An event of Mechanical Support was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Two out of 1641 (0.1%) of subjects experienced Mechanical Support since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Female,100.6,10/3/2024,NI,4446,4641,2993,4755,4114;4119,3221,4315,NA,0;9153495,10/7/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/28/2024 in a 83 year old Male. On 10/07/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,102.71,5/28/2024,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;9153495,10/7/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/28/2024 in a 83 year old Male. On 10/07/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,102.71,5/28/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9966999,10/8/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/10/2024 in a 85 year old Female. On 10/08/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,72.4,9/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9945633,10/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 72 year old Female. On 10/09/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Female,74.2,8/14/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9475067,10/10/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/10/2024 in a 80 year old Female. On 10/10/2024, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Other could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Female,67.9,10/10/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;887398762,10/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/10/2024 in a 89 year old Female. On 10/12/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,51.5,10/10/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9663722,10/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/08/2024 in a 83 year old Female. On 10/14/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,55.6,10/8/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;8761711,10/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/07/2024 in a 84 year old Male. On 10/16/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,64.86,8/7/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9494539,10/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/16/2024 in a 73 year old Female. On 10/17/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Female,62.6,10/16/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;4394156,10/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/15/2024 in a 81 year old Female. On 10/17/2024, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Other could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,92.6,10/15/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9542649,10/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/01/2024 in a 65 year old Female. On 10/17/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,65,Female,82,10/1/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9447884,10/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/15/2024 in a 75 year old Female. On 10/17/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,75,Female,52.5,10/15/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9542649,10/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/01/2024 in a 65 year old Female. On 10/18/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,65,Female,82,10/1/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9783422,10/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/01/2024 in a 54 year old Female. On 10/18/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,54,Female,92.5,10/1/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9494539,10/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/16/2024 in a 73 year old Female. On 10/18/2024, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Female,62.6,10/16/2024,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;9494539,10/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/16/2024 in a 73 year old Female. On 10/18/2024, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Major could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Female,62.6,10/16/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9443698,10/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/15/2024 in a 88 year old Male. On 10/18/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Stroke - Ischemic could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 1641 (0.3%) of subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Male,78,10/15/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;6551447,10/24/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/24/2024 in a 77 year old Male. On 10/24/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,78,10/24/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9689054,10/24/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/11/2024 in a 79 year old Female. On 10/24/2024, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,57.3,9/11/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;680810,10/25/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/16/2024 in a 61 year old Female. On 10/25/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,61,Female,93.1,10/16/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9503901,10/28/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/30/2024 in a 74 year old Female. On 10/28/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,74,Female,50.4,9/30/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9518651,10/29/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/25/2024 in a 84 year old Female. On 10/29/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,69.1,9/25/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9698531,10/29/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/10/2024 in a 84 year old Female. On 10/29/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,68.75,10/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;836814851,10/31/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/21/2024 in a 73 year old Male. On 10/31/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,85,10/21/2024,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;836814851,10/31/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/21/2024 in a 73 year old Male. On 10/31/2024, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Other could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,85,10/21/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;836814851,10/31/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/21/2024 in a 73 year old Male. On 10/31/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,85,10/21/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;2833,11/1/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/25/2024 in a 81 year old Male. On 11/01/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,64.8,10/25/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;2833,11/1/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/25/2024 in a 81 year old Male. On 11/01/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,64.8,10/25/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;424455,11/2/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/22/2024 in a 86 year old Female. On 11/02/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,58.5,10/22/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;205262478,11/5/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/30/2024 in a 69 year old Male. On 11/05/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,69,Male,104,9/30/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;836814851,11/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/21/2024 in a 73 year old Male. On 11/06/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Stroke - Ischemic could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 1641 (0.3%) of subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,85,10/21/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;9621356,11/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/30/2024 in a 84 year old Male. On 11/06/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,69.35,9/30/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9774026,11/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/03/2024 in a 86 year old Male. On 11/06/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,80.5,10/3/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;1077771,11/7/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/07/2024 in a 70 year old Female. On 11/07/2024, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Seven out of 1641 (0.4%) of subjects experienced Bleeding - Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Female,60.1,11/7/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9618574,11/7/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/30/2024 in a 60 year old Male. On 11/07/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,60,Male,78.65,9/30/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9510641,11/8/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/29/2024 in a 56 year old Female. On 11/08/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,56,Female,88,10/29/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9347432,11/8/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/08/2024 in a 86 year old Female. On 11/08/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,48.5,10/8/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9432499,11/8/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/01/2024 in a 87 year old Male. On 11/08/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Male,61.1,10/1/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9487543,11/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/30/2024 in a 89 year old Female. On 11/09/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,55.38,9/30/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;2833,11/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/25/2024 in a 81 year old Male. On 11/09/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,64.8,10/25/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9582798,11/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/17/2024 in a 70 year old Male. On 11/09/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Male,78.5,10/17/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9582798,11/11/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/17/2024 in a 70 year old Male. On 11/11/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Male,78.5,10/17/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;9798846,11/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/12/2024 in a 81 year old Female. On 11/12/2024, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,61.2,11/12/2024,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;8110694,11/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/12/2024 in a 84 year old Male. On 11/12/2024, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Seven out of 1641 (0.4%) of subjects experienced Bleeding - Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,82.5,11/12/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9442306,11/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/10/2024 in a 88 year old Female. On 11/12/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Female,64.5,10/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;7872373,11/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/14/2024 in a 89 year old Female. On 11/12/2024, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,62.9,10/14/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9378407,11/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/01/2024 in a 81 year old Female. On 11/12/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,65,8/1/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9685240,11/13/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/30/2024 in a 68 year old Female. On 11/13/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,68,Female,60.8,9/30/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9829130,11/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/10/2024 in a 80 year old Male. On 11/14/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,60.7,10/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;540990277,11/15/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/14/2024 in a 82 year old Male. On 11/15/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,100.2,11/14/2024,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;9348753,11/15/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/30/2024 in a 88 year old Female. On 11/15/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Female,49.4,9/30/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;724373,11/15/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/12/2024 in a 72 year old Male. On 11/15/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Male,83.2,11/12/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;7271052,11/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 48 year old Female. On 11/18/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,48,Female,75,8/14/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;8726520,11/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/09/2024 in a 93 year old Female. On 11/18/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,93,Female,46.27,10/9/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;7611804,11/19/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/02/2024 in a 79 year old Male. On 11/19/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,85.4,10/2/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;8695168,11/19/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/18/2024 in a 80 year old Female. On 11/19/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Female,54.9,10/18/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9703303,11/19/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/23/2024 in a 82 year old Female. On 11/19/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,87.1,10/23/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;3121473,11/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/22/2024 in a 81 year old Female. On 11/20/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,50,10/22/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9539288,11/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/20/2024 in a 80 year old Male. On 11/20/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,60,11/20/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;9498285,11/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/09/2024 in a 90 year old Male. On 11/20/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Male,121,10/9/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9537623,11/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/21/2024 in a 34 year old Female. On 11/20/2024, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,34,Female,32.2,10/21/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9533126,11/21/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 59 year old Male. On 11/21/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,59,Male,121.6,11/19/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9015454,11/21/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/17/2024 in a 83 year old Male. On 11/21/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,85.7,10/17/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9364320,11/22/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 09/13/2024 in a 83 year old Female. On 11/22/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,89.4,9/13/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;7793200,11/22/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/21/2024 in a 78 year old Female. On 11/22/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,83.8,10/21/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9494539,11/22/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/16/2024 in a 73 year old Female. On 11/22/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Female,62.6,10/16/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8716047,11/22/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/23/2024 in a 83 year old Male. On 11/22/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,120.2,10/23/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9483457,11/22/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/07/2024 in a 79 year old Male. On 11/22/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,95.1,10/7/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9578737,11/25/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 63 year old Male. On 11/25/2024, ICD was reported and is considered a Serious Injury. The relationship of the Serious Injury to the ICD could not be determined based on the limited data received from the registry.","An event of ICD was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Two out of 1641 (0.1%) of subjects experienced ICD since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,63,Male,142.3,11/19/2024,NI,1721,4641,2993,4755,4114;4119,3221,4315,NA,0;9485295,11/25/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/14/2024 in a 77 year old Male. On 11/25/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,60,10/14/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9519441,11/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/26/2024 in a 78 year old Female. On 11/26/2024, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Other could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,79,11/26/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;672183,11/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/22/2024 in a 53 year old Female. On 11/26/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,53,Female,79,10/22/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;7271052,11/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 48 year old Female. On 11/26/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,48,Female,75,8/14/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;747428,11/28/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/21/2024 in a 90 year old Male. On 11/28/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Male,77.6,11/21/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9589268,11/29/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/21/2024 in a 89 year old Female. On 11/29/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,63,11/21/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;886700,11/29/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/16/2024 in a 80 year old Female. On 11/29/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Female,65.5,10/16/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;887398762,12/2/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/10/2024 in a 89 year old Female. On 12/02/2024, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the PCI could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,51.5,10/10/2024,NI,1942,4614,2993,4755,4114;4119,3221,4315,NA,0;9622348,12/2/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/02/2024 in a 79 year old Female. On 12/02/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,56,12/2/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;887398762,12/2/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/10/2024 in a 89 year old Female. On 12/02/2024, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Myocardial Infarction could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,51.5,10/10/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;9483452,12/2/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/14/2024 in a 87 year old Male. On 12/02/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Male,72.6,11/14/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9583950,12/2/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/22/2024 in a 47 year old Female. On 12/02/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,47,Female,118.8,10/22/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;699164,12/2/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/01/2024 in a 72 year old Male. On 12/02/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Male,66,11/1/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9449011,12/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/24/2024 in a 92 year old Female. On 12/03/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,92,Female,68.5,10/24/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;8899884,12/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/31/2024 in a 86 year old Female. On 12/03/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,,10/31/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;4644753,12/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/03/2024 in a 70 year old Male. On 12/03/2024, Mechanical Support was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Mechanical Support could not be determined based on the limited data received from the registry.","An event of Mechanical Support was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Two out of 1641 (0.1%) of subjects experienced Mechanical Support since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Male,76.7,12/3/2024,NI,4446,4641,2993,4755,4114;4119,3221,4315,NA,0;7271052,12/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/14/2024 in a 48 year old Female. On 12/03/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,48,Female,75,8/14/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;783841,12/4/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/22/2024 in a 64 year old Female. On 12/04/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,64,Female,46,11/22/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9595116,12/4/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 70 year old Female. On 12/04/2024, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Device Embolization could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. One out of 1641 (0.1%) of subjects experienced Device Embolization since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Female,87.1,12/4/2024,NI,2687;4438,4614,2933,4755,4114;4119,3221,4315,NA,0;9607959,12/4/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/25/2024 in a 79 year old Male. On 12/04/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,90.7,10/25/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9527008,12/5/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/17/2024 in a 80 year old Female. On 12/05/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Female,82,10/17/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9622348,12/5/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/02/2024 in a 79 year old Female. On 12/05/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,56,12/2/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;9698696,12/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 80 year old Male. On 12/06/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,117,12/5/2024,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;9122155,12/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/04/2024 in a 84 year old Female. On 12/06/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,87,10/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9826781,12/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 76 year old Female. On 12/06/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Female,64.4,12/5/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;2838,12/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/25/2024 in a 73 year old Male. On 12/06/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,86.7,10/25/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9826781,12/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 76 year old Female. On 12/06/2024, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Surgery or Intervention - Unplanned could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 1641 (0.8%) of subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Female,64.4,12/5/2024,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;9477119,12/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/24/2024 in a 83 year old Female. On 12/09/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,50.1,10/24/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9547399,12/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/14/2024 in a 77 year old Female. On 12/09/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,58,11/14/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9547115,12/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/14/2024 in a 93 year old Male. On 12/09/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,93,Male,78,11/14/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;897958925,12/10/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 78 year old Male. On 12/10/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,76.8,12/5/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;8176482,12/11/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/06/2024 in a 70 year old Female. On 12/11/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Female,55.6,11/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9523482,12/11/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 71 year old Female. On 12/11/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,71,Female,112.9,11/19/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9777787,12/11/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/07/2024 in a 78 year old Female. On 12/11/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,83.9,10/7/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;4765353,12/11/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/16/2024 in a 75 year old Male. On 12/11/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,75,Male,82.87,10/16/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;452513,12/11/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/10/2024 in a 59 year old Female. On 12/11/2024, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,59,Female,144,12/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;4106243,12/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/10/2024 in a 90 year old Male. On 12/12/2024, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Other could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Male,70.5,12/10/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;886048,12/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/01/2024 in a 89 year old Female. On 12/12/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,71.1,10/1/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9598332,12/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/09/2024 in a 76 year old Male. On 12/12/2024, Complete Leaflet Clip Detachment was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Complete Leaflet Clip Detachment could not be determined based on the limited data received from the registry.","An event of Complete Leaflet Clip Detachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Two out of 1641 (0.1%) of subjects experienced Complete Leaflet Clip Detachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,72.6,12/9/2024,NI,2687;4438,4614,2933,4755,4114;4119,3221,4315,NA,0;7611804,12/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/02/2024 in a 79 year old Male. On 12/12/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,85.4,10/2/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9598332,12/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/09/2024 in a 76 year old Male. On 12/12/2024, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,72.6,12/9/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;9636997,12/13/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/31/2024 in a 44 year old Female. On 12/13/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,44,Female,127.4,10/31/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9508182,12/13/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/04/2024 in a 86 year old Male. On 12/13/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,53.6,11/4/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;761660740,12/13/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/05/2024 in a 89 year old Female. On 12/13/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,79.5,11/5/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8988506,12/13/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/20/2024 in a 78 year old Female. On 12/13/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,65.9,11/20/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8176211,12/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/06/2024 in a 85 year old Female. On 12/14/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,51,11/6/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9622058,12/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/18/2024 in a 77 year old Male. On 12/14/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,63.5,10/18/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9598332,12/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/09/2024 in a 76 year old Male. On 12/14/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,72.6,12/9/2024,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;13089,12/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 86 year old Male. On 12/14/2024, Deep Vein Thrombosis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Deep Vein Thrombosis could not be determined based on the limited data received from the registry.","An event of Deep Vein Thrombosis was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced Deep Vein Thrombosis since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,91.7,12/5/2024,NI,4440,4614,2993,4755,4114;4119,3221,4315,NA,0;9598332,12/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/09/2024 in a 76 year old Male. On 12/14/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,72.6,12/9/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9316925,12/15/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/10/2024 in a 81 year old Female. On 12/15/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,72.5,12/10/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9576776,12/15/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/27/2024 in a 84 year old Female. On 12/15/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,72.9,11/27/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;4187677,12/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/12/2024 in a 82 year old Female. On 12/16/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,91.2,11/12/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;887737,12/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 78 year old Female. On 12/16/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,67,12/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9508182,12/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/04/2024 in a 86 year old Male. On 12/16/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,53.6,11/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9818768,12/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/13/2024 in a 79 year old Male. On 12/16/2024, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,98.9,11/13/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9179383,12/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 90 year old Male. On 12/17/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Male,77.1,12/4/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9573740,12/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/12/2024 in a 79 year old Female. On 12/17/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,70.1,11/12/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9378407,12/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/01/2024 in a 81 year old Female. On 12/17/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,65,8/1/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9587894,12/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/16/2024 in a 74 year old Female. On 12/18/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,74,Female,102.2,12/16/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;3121473,12/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/22/2024 in a 81 year old Female. On 12/18/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,50,10/22/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;9689858,12/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 77 year old Male. On 12/18/2024, A Blank or unknown adverse event was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Blank or Unknown could not be determined based on the limited data received from the registry.","An event of blank or unknown adverse event was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Two out of 1641 (0.1%) of subjects experienced Blank or Unknown since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,91.4,11/19/2024,NI,4446,4614,2993,4755,4114;4119,3221,4315,NA,0;760021,12/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/15/2024 in a 86 year old Male. On 12/18/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,68.9,10/15/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9689858,12/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 77 year old Male. On 12/18/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,91.4,11/19/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8162544,12/19/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/20/2024 in a 81 year old Female. On 12/19/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,61,11/20/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9799649,12/19/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/19/2024 in a 67 year old Female. On 12/19/2024, Bleeding - Retroperitoneal was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Retroperitoneal could not be determined based on the limited data received from the registry.","An event of Bleeding - Retroperitoneal was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced Bleeding - Retroperitoneal since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,67,Female,68,12/19/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;8176537,12/19/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 78 year old Male. On 12/19/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,64,11/19/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9623841,12/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/19/2024 in a 76 year old Male. On 12/20/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,89.7,12/19/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9521320,12/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/21/2024 in a 88 year old Female. On 12/20/2024, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Female,48.9,11/21/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;1077773,12/22/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 73 year old Male. On 12/22/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,98,12/5/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;680810,12/23/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/16/2024 in a 61 year old Female. On 12/23/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,61,Female,93.1,10/16/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;1231912,12/23/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/25/2024 in a 66 year old Male. On 12/23/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Male,98.88,11/25/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9777924,12/25/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/19/2024 in a 72 year old Female. On 12/25/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Female,81.6,12/19/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9528529,12/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/18/2024 in a 75 year old Male. On 12/26/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,75,Male,104,11/18/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9622348,12/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/02/2024 in a 79 year old Female. On 12/26/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,56,12/2/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;9316925,12/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/10/2024 in a 81 year old Female. On 12/26/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,72.5,12/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;887397,12/27/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/18/2024 in a 68 year old Female. On 12/27/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,68,Female,110.3,11/18/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8176211,12/29/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/06/2024 in a 85 year old Female. On 12/29/2024, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,51,11/6/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9622348,12/30/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/02/2024 in a 79 year old Female. On 12/30/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,56,12/2/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;1077771,12/30/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/07/2024 in a 70 year old Female. On 12/30/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Female,60.1,11/7/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8176547,12/30/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/26/2024 in a 76 year old Male. On 12/30/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,61.3,11/26/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;1305071,12/31/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 56 year old Female. On 12/31/2024, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Dialysis (New Requirement) could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Dialysis (New Requirement) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,56,Female,74.9,12/17/2024,NI,2041,4614,2993,4755,4114;4119,3221,4315,NA,0;9747308,12/31/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 79 year old Female. On 12/31/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,53,12/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9577270,12/31/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/20/2024 in a 78 year old Male. On 12/31/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,108.8,11/20/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8541015,1/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/12/2024 in a 91 year old Female. On 01/02/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,91,Female,60.1,12/12/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9226759,1/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/27/2024 in a 78 year old Female. On 01/02/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,51.07,11/27/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9499104,1/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/06/2024 in a 71 year old Female. On 01/02/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,71,Female,83.6,11/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;887738,1/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 81 year old Male. On 01/02/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,82.6,12/4/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;7868610,1/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 81 year old Male. On 01/03/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,69.7,12/17/2024,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;9049753,1/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/12/2024 in a 41 year old Female. On 01/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,41,Female,54.2,11/12/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9545686,1/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/02/2024 in a 78 year old Female. On 01/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,66.9,12/2/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9595116,1/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 70 year old Female. On 01/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Female,87.1,12/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;961583439,1/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 87 year old Female. On 01/03/2025, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Major could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,65.8,12/5/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;7868610,1/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 81 year old Male. On 01/03/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,69.7,12/17/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;4204193,1/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/03/2024 in a 79 year old Female. On 01/04/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,53.2,12/3/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;8176211,1/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/06/2024 in a 85 year old Female. On 01/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,51,11/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;853267,1/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/02/2025 in a 91 year old Female. On 01/06/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,91,Female,75,1/2/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9836460,1/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 83 year old Female. On 01/06/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,74.6,11/19/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9896924,1/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/06/2025 in a 81 year old Male. On 01/06/2025, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,117,1/6/2025,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;9896924,1/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/06/2025 in a 81 year old Male. On 01/06/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,117,1/6/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;747428,1/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/21/2024 in a 90 year old Male. On 01/06/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Male,77.6,11/21/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9533343,1/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/14/2024 in a 84 year old Male. On 01/07/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,59.4,11/14/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9896924,1/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/06/2025 in a 81 year old Male. On 01/07/2025, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Seven out of 1641 (0.4%) of subjects experienced Bleeding - Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,117,1/6/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9716503,1/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/07/2025 in a 80 year old Male. On 01/07/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Arrest could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 1641 (0.3%) of subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,117.4,1/7/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;9571097,1/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/06/2024 in a 84 year old Female. On 01/08/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,46.3,12/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9662575,1/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/10/2024 in a 83 year old Female. On 01/08/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,74.8,12/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9739659,1/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/12/2024 in a 82 year old Female. On 01/08/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,70.3,11/12/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;747509409,1/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/18/2024 in a 46 year old Male. On 01/08/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,46,Male,79.38,12/18/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;747509409,1/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/18/2024 in a 46 year old Male. On 01/08/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,46,Male,79.38,12/18/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9747467,1/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 79 year old Male. On 01/08/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,76,12/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9518629,1/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/21/2024 in a 75 year old Female. On 01/08/2025, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,75,Female,92.5,11/21/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;1240392,1/9/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 71 year old Male. On 01/09/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,71,Male,88.5,11/19/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9601925,1/9/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/09/2025 in a 73 year old Male. On 01/09/2025, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Seven out of 1641 (0.4%) of subjects experienced Bleeding - Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,110,1/9/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;6748263,1/9/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/06/2024 in a 78 year old Female. On 01/09/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,NI,11/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9544836,1/9/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/02/2024 in a 86 year old Male. On 01/09/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,71.1,12/2/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8176543,1/10/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/06/2024 in a 84 year old Female. On 01/10/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,62.1,11/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9601925,1/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/09/2025 in a 73 year old Male. On 01/11/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,110,1/9/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;9716503,1/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/07/2025 in a 80 year old Male. On 01/11/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Arrest could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 1641 (0.3%) of subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,117.4,1/7/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;9624835,1/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/13/2025 in a 81 year old Female. On 01/13/2025, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Seven out of 1641 (0.4%) of subjects experienced Bleeding - Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,80,1/13/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;7868610,1/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 81 year old Male. On 01/13/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,69.7,12/17/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9497003,1/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/08/2024 in a 77 year old Female. On 01/13/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,86,11/8/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9593113,1/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 89 year old Female. On 01/13/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,57,12/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9624835,1/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/13/2025 in a 81 year old Female. On 01/13/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,80,1/13/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9624835,1/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/13/2025 in a 81 year old Female. On 01/13/2025, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Surgery or Intervention - Unplanned could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 1641 (0.8%) of subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,80,1/13/2025,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;7856877,1/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/14/2025 in a 86 year old Female. On 01/14/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,51,1/14/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;221763889,1/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/14/2024 in a 84 year old Female. On 01/14/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,55.6,11/14/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9546563,1/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/11/2024 in a 75 year old Female. On 01/14/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,75,Female,82,12/11/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9574333,1/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/10/2024 in a 62 year old Female. On 01/14/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,62,Female,103.63,12/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;961583439,1/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 87 year old Female. On 01/14/2025, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Surgery or Intervention - Unplanned could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 1641 (0.8%) of subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,65.8,12/5/2024,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;9155239,1/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/22/2024 in a 77 year old Male. On 01/14/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,74.4,11/22/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8469545,1/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/20/2024 in a 72 year old Female. On 01/14/2025, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Female,129,11/20/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;13094,1/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/06/2024 in a 78 year old Female. On 01/16/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,114.6,12/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9696065,1/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/15/2025 in a 89 year old Male. On 01/16/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Male,83.1,1/15/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;9716503,1/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/07/2025 in a 80 year old Male. On 01/16/2025, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Dialysis (New Requirement) could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Dialysis (New Requirement) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,117.4,1/7/2025,NI,2041,4614,2993,4755,4114;4119,3221,4315,NA,0;719391,1/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/25/2024 in a 78 year old Female. On 01/17/2025, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Myocardial Infarction could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,50,11/25/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;793866854,1/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/16/2024 in a 88 year old Male. On 01/17/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Male,93.3,12/16/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9576326,1/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/10/2024 in a 85 year old Male. On 01/17/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Male,126.8,12/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;401872,1/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/22/2024 in a 72 year old Female. On 01/20/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Female,77.5,11/22/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8087397,1/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/14/2025 in a 89 year old Male. On 01/20/2025, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Dialysis (New Requirement) could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Dialysis (New Requirement) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Male,80.1,1/14/2025,NI,2041,4614,2993,4755,4114;4119,3221,4315,NA,0;822303,1/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 87 year old Male. On 01/20/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Male,77.9,12/17/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;795898,1/21/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/02/2024 in a 84 year old Female. On 01/21/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,65,12/2/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;5716,1/21/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/16/2024 in a 70 year old Male. On 01/21/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Male,73.9,12/16/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9533126,1/21/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 59 year old Male. On 01/21/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,59,Male,121.6,11/19/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9049052,1/22/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/20/2024 in a 75 year old Female. On 01/22/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,75,Female,57.2,11/20/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8160394,1/22/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 71 year old Male. On 01/22/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,71,Male,88.5,12/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9483452,1/22/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/14/2024 in a 87 year old Male. On 01/22/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Male,72.6,11/14/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9546716,1/22/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/06/2024 in a 62 year old Male. On 01/22/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,62,Male,82,12/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8176271,1/23/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/23/2024 in a 81 year old Male. On 01/23/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,122.3,12/23/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9779743,1/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/27/2025 in a 33 year old Female. On 01/27/2025, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,33,Female,92.3,1/27/2025,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;9779743,1/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/27/2025 in a 33 year old Female. On 01/27/2025, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Major could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,33,Female,92.3,1/27/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;4204193,1/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/03/2024 in a 79 year old Female. On 01/28/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,53.2,12/3/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9966477,1/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/28/2025 in a 76 year old Female. On 01/28/2025, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Other could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Female,55,1/28/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;825999,1/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/19/2024 in a 83 year old Female. On 01/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,62.5,12/19/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9602171,1/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/18/2024 in a 71 year old Male. On 01/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,71,Male,66.7,12/18/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9419276,1/29/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/16/2025 in a 91 year old Female. On 01/29/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,91,Female,68.7,1/16/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;6747423,1/29/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/20/2024 in a 81 year old Female. On 01/29/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,84.4,12/20/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9186780,1/29/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 70 year old Female. On 01/29/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Female,80,12/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;754915,1/29/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/28/2025 in a 53 year old Male. On 01/29/2025, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,53,Male,88.6,1/28/2025,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;9690401,1/30/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/19/2024 in a 52 year old Female. On 01/30/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,52,Female,82.5,12/19/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;1231910,1/30/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/25/2024 in a 82 year old Male. On 01/30/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,89.36,11/25/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;7868610,1/31/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 81 year old Male. On 01/31/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,69.7,12/17/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;7699246,1/31/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/29/2025 in a 84 year old Female. On 01/31/2025, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,45.4,1/29/2025,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;9917758,1/31/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/31/2025 in a 92 year old Female. On 01/31/2025, Dialysis (New Requirement) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Dialysis (New Requirement) could not be determined based on the limited data received from the registry.","An event of Dialysis (New Requirement) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Dialysis (New Requirement) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,92,Female,83,1/31/2025,NI,2041,4614,2993,4755,4114;4119,3221,4315,NA,0;9584970,1/31/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 78 year old Female. On 01/31/2025, Transient Ischemic Attack (TIA) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Transient Ischemic Attack (TIA) could not be determined based on the limited data received from the registry.","An event of Transient Ischemic Attack (TIA) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. One out of 1641 (0.1%) of subjects experienced Transient Ischemic Attack (TIA) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,76.5,12/17/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;1231912,2/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/25/2024 in a 66 year old Male. On 02/02/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Male,98.88,11/25/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9994195,2/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/17/2025 in a 90 year old Female. On 02/03/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Female,46.7,1/17/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9994195,2/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/17/2025 in a 90 year old Female. On 02/03/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Female,46.7,1/17/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9110294,2/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/06/2024 in a 80 year old Female. On 02/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Female,82,11/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9734335,2/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/11/2024 in a 82 year old Female. On 02/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,59.5,12/11/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9662696,2/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 66 year old Male. On 02/03/2025, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Male,114.3,12/17/2024,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;7748668,2/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/23/2025 in a 83 year old Female. On 02/04/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,64.4,1/23/2025,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;9584539,2/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/20/2024 in a 79 year old Female. On 02/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,108,11/20/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9699598,2/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/09/2025 in a 77 year old Female. On 02/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,101,1/9/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9624835,2/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/13/2025 in a 81 year old Female. On 02/05/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,80,1/13/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9137565,2/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/04/2024 in a 82 year old Male. On 02/05/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,90.6,12/4/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9709790,2/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/22/2025 in a 78 year old Female. On 02/06/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,57.3,1/22/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;887893,2/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/09/2024 in a 84 year old Male. On 02/06/2025, A Blank or unknown adverse event was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Blank or Unknown could not be determined based on the limited data received from the registry.","An event of blank or unknown adverse event was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Two out of 1641 (0.1%) of subjects experienced Blank or Unknown since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,78.1,12/9/2024,NI,4446,4614,2993,4755,4114;4119,3221,4315,NA,0;8829708,2/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/07/2025 in a 70 year old Female. On 02/07/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,70,Female,88.1,1/7/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;7868610,2/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 81 year old Male. On 02/07/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,69.7,12/17/2024,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;9007221,2/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/22/2025 in a 83 year old Male. On 02/07/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,80,1/22/2025,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;9662696,2/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 66 year old Male. On 02/07/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Male,114.3,12/17/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;7868610,2/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 81 year old Male. On 02/07/2025, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,69.7,12/17/2024,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;7868610,2/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 81 year old Male. On 02/08/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,69.7,12/17/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9709790,2/10/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/22/2025 in a 78 year old Female. On 02/10/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,57.3,1/22/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;9744852,2/10/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/14/2025 in a 79 year old Female. On 02/10/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,64.6,1/14/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9804750,2/10/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/19/2024 in a 81 year old Female. On 02/10/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,72.7,11/19/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9696065,2/10/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/15/2025 in a 89 year old Male. On 02/10/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Male,83.1,1/15/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;521088923,2/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 73 year old Female. On 02/11/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Female,88.8,12/17/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9824102,2/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/12/2025 in a 76 year old Female. On 02/12/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Female,64.3,2/12/2025,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;708122584,2/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/02/2024 in a 89 year old Female. On 02/12/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,64.9,12/2/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;854446,2/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/09/2025 in a 66 year old Female. On 02/12/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Female,94.95,1/9/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9737343,2/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/08/2025 in a 93 year old Female. On 02/13/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,93,Female,68.6,1/8/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9831546,2/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/16/2025 in a 82 year old Female. On 02/13/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,60.5,1/16/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9480421,2/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/11/2025 in a 62 year old Male. On 02/13/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,62,Male,115,2/11/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;9012895,2/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/04/2025 in a 74 year old Female. On 02/14/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,74,Female,44.2,2/4/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;7106962,2/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/03/2025 in a 87 year old Male. On 02/14/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Male,76.7,1/3/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8949028,2/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/10/2024 in a 83 year old Male. On 08/09/2024, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,127,7/10/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8043043,2/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/10/2025 in a 74 year old Female. On 02/15/2025, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Life Threatening could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. One out of 1641 (0.1%) of subjects experienced Bleeding - Life Threatening since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,74,Female,85.6,2/10/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9709790,2/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/22/2025 in a 78 year old Female. On 02/15/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,57.3,1/22/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8043043,2/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/10/2025 in a 74 year old Female. On 02/15/2025, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Major could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Eight out of 1641 (0.5%) of subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,74,Female,85.6,2/10/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9815598,2/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/12/2025 in a 74 year old Female. On 02/16/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,74,Female,53.6,2/12/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;8043043,2/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/10/2025 in a 74 year old Female. On 02/16/2025, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Surgery or Intervention - Unplanned could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 1641 (0.8%) of subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,74,Female,85.6,2/10/2025,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;9113809,2/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/21/2024 in a 92 year old Female. On 02/17/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Stroke - Ischemic could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 1641 (0.3%) of subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,92,Female,45.4,5/21/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;9840198,2/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/15/2025 in a 80 year old Male. On 02/17/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,81.8,1/15/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;14680,2/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/22/2025 in a 68 year old Male. On 02/17/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,68,Male,172.37,1/22/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9933104,2/18/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/15/2025 in a 86 year old Female. On 02/18/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,90.1,1/15/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9777924,2/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/19/2024 in a 72 year old Female. On 02/19/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Female,81.6,12/19/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9826737,2/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/14/2025 in a 83 year old Female. On 02/19/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,84,1/14/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9906045,2/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/14/2025 in a 76 year old Male. On 02/19/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,108,1/14/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9628828,2/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/17/2025 in a 94 year old Male. On 02/20/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,94,Male,70.3,1/17/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9699647,2/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/17/2025 in a 83 year old Male. On 02/20/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,76,1/17/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10053705,2/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/07/2025 in a 76 year old Female. On 02/24/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Female,85.1,2/7/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;949770,2/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/21/2025 in a 52 year old Female. On 02/24/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,52,Female,78,2/21/2025,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;949770,2/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/21/2025 in a 52 year old Female. On 02/24/2025, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Other could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,52,Female,78,2/21/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;7473520,2/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/22/2025 in a 87 year old Female. On 02/24/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,39.4,1/22/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9509870,2/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/23/2025 in a 67 year old Male. On 02/24/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,67,Male,89.3,1/23/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9692615,2/25/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/22/2025 in a 90 year old Female. On 02/25/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Female,64.9,1/22/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10052780,2/26/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/24/2025 in a 101 year old Female. On 02/26/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,101,Female,52,1/24/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;122987586,2/26/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/16/2024 in a 89 year old Female. On 02/26/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,73.1,12/16/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9636818,2/26/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/17/2025 in a 61 year old Male. On 02/26/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,61,Male,99,1/17/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;2156,2/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/24/2025 in a 88 year old Female. On 02/27/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Female,67.3,1/24/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9637811,2/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/21/2025 in a 77 year old Female. On 02/27/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,60,1/21/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9434846,2/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/26/2025 in a 82 year old Male. On 02/27/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Arrest could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 1641 (0.3%) of subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,68,2/26/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;9434846,2/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/26/2025 in a 82 year old Male. On 02/27/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Permanent Pacemaker could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 1641 (0.7%) of subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,68,2/26/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;9791093,2/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/27/2025 in a 82 year old Female. On 02/28/2025, Percutaneous Coronary Intervention was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Percutaneous Coronary Intervention could not be determined based on the limited data received from the registry.","An event of Percutaneous Coronary Intervention was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced Percutaneous Coronary Intervention since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,57.6,2/27/2025,NI,1942,4614,2993,4755,4114;4119,3221,4315,NA,0;13109,2/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/10/2025 in a 62 year old Female. On 02/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,62,Female,61.8,2/10/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;12678,2/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/30/2025 in a 84 year old Male. On 02/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,76.2,1/30/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9928910,3/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/21/2025 in a 93 year old Female. On 03/02/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,93,Female,70.4,1/21/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9609967,3/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/22/2025 in a 80 year old Female. On 03/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Female,52.3,1/22/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9760995,3/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/30/2025 in a 83 year old Female. On 03/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,61.7,1/30/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9913709,3/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/23/2025 in a 89 year old Female. On 03/04/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,79.5,1/23/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;10060819,3/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/14/2025 in a 81 year old Female. On 03/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,77.9,1/14/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9048593,3/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/28/2025 in a 59 year old Female. On 03/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,59,Female,54,1/28/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;7669923,3/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/27/2025 in a 75 year old Male. On 03/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,75,Male,107.5,1/27/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8468267,3/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/17/2025 in a 83 year old Male. On 03/05/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,79.83,2/17/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9969729,3/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/28/2025 in a 76 year old Female. On 03/05/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Female,65.5,1/28/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9752017,3/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/27/2025 in a 85 year old Female. On 03/07/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,96.5,2/27/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9761297,3/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/30/2025 in a 79 year old Male. On 03/07/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,77.1,1/30/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9915165,3/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/06/2025 in a 90 year old Female. On 03/08/2025, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Female,68,3/6/2025,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;9473090,3/9/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/26/2024 in a 84 year old Male. On 03/09/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,70.6,7/26/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9473090,3/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/26/2024 in a 84 year old Male. On 03/11/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,70.6,7/26/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9783705,3/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/10/2025 in a 92 year old Female. On 03/11/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,92,Female,64.9,3/10/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;3895192,3/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/30/2025 in a 82 year old Male. On 03/11/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,71.8,1/30/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9783705,3/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/10/2025 in a 92 year old Female. On 03/12/2025, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Hematoma at Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,92,Female,64.9,3/10/2025,NI,1884,4614,2993,4755,4114;4119,3221,4315,NA,0;9489433,3/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/11/2025 in a 86 year old Female. On 03/12/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,66.4,2/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;793676,3/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/06/2025 in a 80 year old Male. On 03/12/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,95.6,1/6/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9897762,3/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 78 year old Male. On 03/13/2025, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Access Site could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Seven out of 1641 (0.4%) of subjects experienced Bleeding - Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,61.1,3/13/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;996878,3/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/12/2025 in a 89 year old Male. On 03/13/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Male,78.5,3/12/2025,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;309079364,3/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/21/2025 in a 78 year old Female. On 03/13/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,76.9,1/21/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9983895,3/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/11/2025 in a 91 year old Female. On 03/13/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,91,Female,73.8,2/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9897762,3/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 78 year old Male. On 03/13/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,61.1,3/13/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9897762,3/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 78 year old Male. On 03/13/2025, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Surgery or Intervention - Unplanned could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 1641 (0.8%) of subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,61.1,3/13/2025,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;9897762,3/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 78 year old Male. On 03/14/2025, Bleeding - Retroperitoneal was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Retroperitoneal could not be determined based on the limited data received from the registry.","An event of Bleeding - Retroperitoneal was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced Bleeding - Retroperitoneal since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,61.1,3/13/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9897762,3/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 78 year old Male. On 03/14/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,61.1,3/13/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9775305,3/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/19/2025 in a 82 year old Male. On 03/14/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,85.8,2/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;949783,3/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/19/2025 in a 95 year old Male. On 03/15/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,95,Male,67.59,2/19/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9915165,3/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/06/2025 in a 90 year old Female. On 03/15/2025, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Female,68,3/6/2025,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;9915165,3/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/06/2025 in a 90 year old Female. On 03/16/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Female,68,3/6/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9747929,3/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/20/2025 in a 87 year old Female. On 03/17/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,42.8,2/20/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;19824,3/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/12/2025 in a 88 year old Male. On 03/17/2025, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Other could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Male,62.6,3/12/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;801013093,3/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/17/2025 in a 79 year old Female. On 03/17/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,84.96,2/17/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9411460,3/18/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/19/2025 in a 82 year old Female. On 03/18/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,54,2/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9813570,3/18/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/25/2025 in a 84 year old Female. On 03/18/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,57.2,2/25/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9791093,3/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/27/2025 in a 82 year old Female. On 03/19/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,57.6,2/27/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;2186,3/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/28/2025 in a 78 year old Female. On 03/19/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,84.7,2/28/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9742070,3/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/19/2025 in a 85 year old Female. On 03/19/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,84,2/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;925646161,3/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/11/2025 in a 63 year old Male. On 03/19/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,63,Male,80.3,2/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;6382725,3/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/19/2025 in a 83 year old Female. On 03/19/2025, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,56.5,3/19/2025,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;2971,3/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/14/2025 in a 50 year old Female. On 03/20/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Cardiac Surgery or Intervention - Other Unplanned could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,50,Female,75.2,3/14/2025,NI,4453,4624,2993,4755,4114;4119,3221,4315,NA,0;2198840,3/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/25/2025 in a 77 year old Male. On 03/20/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,99.8,2/25/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9996296,3/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/13/2025 in a 75 year old Male. On 03/20/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,75,Male,86.4,2/13/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;2971,3/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/14/2025 in a 50 year old Female. On 03/20/2025, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,50,Female,75.2,3/14/2025,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;9923348,3/21/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/24/2025 in a 73 year old Female. On 03/21/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Female,70.5,2/24/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;7670805,3/21/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/21/2025 in a 79 year old Female. On 03/21/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,69.8,3/21/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9897762,3/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 78 year old Male. On 03/24/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,61.1,3/13/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9831636,3/25/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/18/2025 in a 84 year old Male. On 03/25/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,84,2/18/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;203509,3/25/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/26/2025 in a 85 year old Female. On 03/25/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,41.5,2/26/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;754915,3/25/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/28/2025 in a 53 year old Male. On 03/25/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,53,Male,88.6,1/28/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;10375,3/25/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/13/2025 in a 68 year old Male. On 03/25/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,68,Male,93,2/13/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9897762,3/25/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 78 year old Male. On 03/25/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,61.1,3/13/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10052456,3/26/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/16/2025 in a 66 year old Female. On 03/26/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Female,57.2,1/16/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;5671499,3/26/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/21/2025 in a 82 year old Female. On 03/26/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,44.9,1/21/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;203509,3/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/26/2025 in a 85 year old Female. On 03/27/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,41.5,2/26/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;949783,3/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/19/2025 in a 95 year old Male. On 03/27/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,95,Male,67.59,2/19/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;6676239,3/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/30/2025 in a 89 year old Male. On 03/27/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Male,72.3,1/30/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9921263,3/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/20/2025 in a 93 year old Female. On 03/27/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,93,Female,71.4,2/20/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9417104,3/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/27/2025 in a 86 year old Male. On 03/27/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Vascular Complication - Minor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 23 out of 1641 (1.4%) of subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,64.7,3/27/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;922874,3/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/11/2025 in a 78 year old Female. On 03/28/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,40.1,3/11/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9831607,3/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/20/2025 in a 76 year old Female. On 03/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Female,60.4,2/20/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;754915,3/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/28/2025 in a 53 year old Male. On 03/28/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,53,Male,88.6,1/28/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;9534613,3/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/06/2025 in a 78 year old Male. On 03/28/2025, ICD was reported and is considered a Serious Injury. The relationship of the Serious Injury to the ICD could not be determined based on the limited data received from the registry.","An event of ICD was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Two out of 1641 (0.1%) of subjects experienced ICD since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,53.8,3/6/2025,NI,1721,4641,2993,4755,4114;4119,3221,4315,NA,0;9841003,3/30/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/10/2025 in a 88 year old Female. On 03/30/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Female,53.1,2/10/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;754915,3/30/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/28/2025 in a 53 year old Male. On 03/30/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,53,Male,88.6,1/28/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;9752453,3/31/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/24/2025 in a 68 year old Female. On 03/31/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,68,Female,81.8,2/24/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;2198,3/31/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/28/2025 in a 73 year old Male. On 03/31/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,90.6,2/28/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9892216,3/31/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/27/2025 in a 84 year old Male. On 03/31/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,81.19,2/27/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9745061,4/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/14/2025 in a 81 year old Male. On 04/01/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,64.6,3/14/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9922117,4/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/07/2025 in a 72 year old Female. On 04/01/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Female,62.4,3/7/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;1151776,4/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/28/2025 in a 68 year old Male. On 04/01/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,68,Male,81.7,1/28/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8161891,4/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/06/2025 in a 81 year old Male. On 04/01/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,83.2,3/6/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10064343,4/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/19/2025 in a 84 year old Female. On 04/01/2025, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission (Valve Related) could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 15 out of 1641 (0.9%) of subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,84.8,3/19/2025,NI,4453,4607,2993,4755,4114;4119,3221,4315,NA,0;647946696,4/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/13/2025 in a 82 year old Female. On 04/02/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,52.9,2/13/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;535453675,4/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/03/2025 in a 80 year old Male. On 04/02/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,60.3,3/3/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10064343,4/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/19/2025 in a 84 year old Female. On 04/02/2025, Reintervention - Tricuspid Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Reintervention - Tricuspid Valve could not be determined based on the limited data received from the registry.","An event of Reintervention - Tricuspid Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 1641 (1.0%) of subjects experienced Reintervention - Tricuspid Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,84.8,3/19/2025,NI,4453,4641,2993,4755,4114;4119,3221,4315,NA,0;8351965,4/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/03/2025 in a 86 year old Female. On 04/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,55,3/3/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;922874,4/3/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/11/2025 in a 78 year old Female. On 04/03/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,40.1,3/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10013100,4/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/05/2025 in a 89 year old Female. On 04/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Female,51.3,3/5/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;3767,4/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/19/2025 in a 78 year old Male. On 04/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Male,73,2/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9703031,4/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/11/2025 in a 79 year old Male. On 04/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,91.1,2/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9759799,4/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/03/2025 in a 90 year old Male. On 04/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Male,93.5,3/3/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9791595,4/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/03/2025 in a 71 year old Male. On 04/04/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,71,Male,57.7,3/3/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9598832,4/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/06/2025 in a 79 year old Female. On 04/07/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,74,3/6/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9815180,4/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/20/2025 in a 57 year old Male. On 04/07/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,57,Male,95.3,2/20/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;9914401,4/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/06/2025 in a 86 year old Female. On 04/08/2025, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the PCI could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,63,3/6/2025,NI,1942,4614,2993,4755,4114;4119,3221,4315,NA,0;203509,4/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/26/2025 in a 85 year old Female. On 04/08/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,41.5,2/26/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;8872342,4/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/16/2024 in a 87 year old Female. On 04/08/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,51.6,7/16/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9436862,4/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/03/2025 in a 88 year old Female. On 04/08/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,88,Female,60.7,3/3/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9735270,4/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/26/2025 in a 73 year old Male. On 04/08/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Male,84.1,2/26/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9897714,4/9/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/04/2025 in a 83 year old Male. On 04/09/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,105,3/4/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10059361,4/9/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/05/2025 in a 78 year old Female. On 04/09/2025, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,90.3,3/5/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8826847,4/9/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 06/06/2024 in a 84 year old Female. On 07/03/2024, Worsening Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Worsening Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Worsening Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 14 out of 1641 (0.9%) of subjects experienced Worsening Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,85.3,6/6/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8087397,4/10/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/14/2025 in a 89 year old Male. On 04/10/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,89,Male,80.1,1/14/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9926511,4/10/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/19/2025 in a 77 year old Male. On 04/10/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,79.2,3/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9798267,4/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/11/2025 in a 38 year old Female. On 04/11/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,38,Female,70.8,3/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10012486,4/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/21/2025 in a 83 year old Male. On 04/11/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,59,3/21/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;112121305,4/11/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/10/2025 in a 91 year old Male. On 04/11/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,91,Male,59.6,3/10/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9375368,4/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/20/2025 in a 77 year old Female. On 04/14/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,74.9,3/20/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9375368,4/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/20/2025 in a 77 year old Female. On 04/14/2025, Deep Vein Thrombosis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Deep Vein Thrombosis could not be determined based on the limited data received from the registry.","An event of Deep Vein Thrombosis was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced Deep Vein Thrombosis since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,74.9,3/20/2025,NI,4440,4614,2993,4755,4114;4119,3221,4315,NA,0;6990315,4/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/03/2025 in a 82 year old Male. On 04/14/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Male,76,3/3/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8760859,4/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/11/2025 in a 87 year old Female. On 04/15/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,76.6,3/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9718291,4/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/11/2025 in a 84 year old Female. On 04/15/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,63,3/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10050069,4/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/12/2025 in a 72 year old Male. On 04/15/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,72,Male,61,3/12/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9887090,4/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/05/2025 in a 74 year old Male. On 04/15/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,74,Male,71.2,3/5/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10053705,4/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/07/2025 in a 76 year old Female. On 04/16/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Female,85.1,2/7/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;312092110,4/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/19/2025 in a 67 year old Female. On 04/16/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,67,Female,70.3,3/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;733286130,4/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/19/2025 in a 77 year old Female. On 04/16/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,68.7,3/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9034278,4/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/21/2025 in a 87 year old Female. On 04/16/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,50,3/21/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10035068,4/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/11/2025 in a 93 year old Male. On 04/17/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,93,Male,86,3/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9807220,4/22/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/24/2025 in a 86 year old Female. On 04/22/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Female,43.3,3/24/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9966421,4/22/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/16/2024 in a 76 year old Male. On 04/22/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,76,Male,83.9,8/16/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10013234,4/23/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/05/2025 in a 82 year old Female. On 04/23/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,82,Female,39.9,3/5/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9992876,4/23/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/27/2025 in a 87 year old Female. On 04/23/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,78.4,3/27/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9794522,4/23/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/18/2025 in a 83 year old Male. On 04/23/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,80.7,3/18/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9177119,4/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/24/2025 in a 80 year old Female. On 04/24/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Female,70.4,3/24/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9685446,4/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 86 year old Male. On 04/24/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,86,Male,89.54,3/13/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9720427,4/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/24/2025 in a 80 year old Male. On 04/24/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,90,3/24/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9375368,4/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/20/2025 in a 77 year old Female. On 04/27/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,74.9,3/20/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;10026836,4/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/25/2025 in a 85 year old Female. On 04/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,71.7,2/25/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10048174,4/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/27/2025 in a 85 year old Female. On 04/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,85,Female,57.9,3/27/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9784910,4/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/19/2025 in a 67 year old Female. On 04/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,67,Female,61.7,3/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9915265,4/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/27/2025 in a 84 year old Male. On 04/28/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,90.1,3/27/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9166096,4/29/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/21/2024 in a 92 year old Male. On 07/22/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,92,Male,71.7,5/21/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;961585561,4/30/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 73 year old Female. On 04/30/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Atrial Fibrillation could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,73,Female,75.7,3/13/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;6228577,4/30/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/20/2025 in a 84 year old Male. On 04/30/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Male,85.3,3/20/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9745061,4/30/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/14/2025 in a 81 year old Male. On 04/30/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,64.6,3/14/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;10023995,5/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/11/2025 in a 81 year old Female. On 05/01/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Female,64.6,3/11/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;5786649,5/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/12/2025 in a 84 year old Female. On 05/01/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,84,Female,107.41,3/12/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8468267,5/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/17/2025 in a 83 year old Male. On 05/01/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,79.83,2/17/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9933992,5/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/05/2025 in a 81 year old Male. On 05/01/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,81,Male,94.34,3/5/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9153067,5/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/28/2024 in a 83 year old Male. On 08/06/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Male,59.51,5/28/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9806884,5/7/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/27/2025 in a 79 year old Female. On 05/07/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Female,60,2/27/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;42946680,5/8/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/26/2025 in a 66 year old Female. On 05/08/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,66,Female,92.7,3/26/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;958825,5/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/19/2025 in a 90 year old Female. On 05/12/2025, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Female,54,3/19/2025,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;8872342,5/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/16/2024 in a 87 year old Female. On 05/16/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,87,Female,51.6,7/16/2024,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;9057080,5/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 04/08/2024 in a 77 year old Male. On 05/20/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Male,70,4/8/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9375368,5/21/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/20/2025 in a 77 year old Female. On 05/21/2025, Readmission - Heart Failure was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Readmission - Heart Failure could not be determined based on the limited data received from the registry.","An event of Readmission - Heart Failure was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 62 out of 1641 (3.8%) of subjects experienced Readmission - Heart Failure since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,77,Female,74.9,3/20/2025,NI,4446,4607,2993,4755,4114;4119,3221,4315,NA,0;6998938,5/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/24/2024 in a 79 year old Male. On 07/05/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,79,Male,88.4,5/24/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;9220866,5/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/22/2024 in a 83 year old Female. On 05/28/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Stroke - Ischemic could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 1641 (0.3%) of subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,83,Female,51.7,8/22/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;17356253,5/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/05/2025 in a 90 year old Male. On 05/28/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Male,90.7,3/5/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9256266,6/16/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 06/27/2024 in a 80 year old Male. On 08/15/2024, Recurrent Tricuspid Regurgitation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Recurrent Tricuspid Regurgitation could not be determined based on the limited data received from the registry.","An event of Recurrent Tricuspid Regurgitation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 353 out of 1641 (21.5%) of subjects experienced Recurrent Tricuspid Regurgitation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,80,Male,83.2,6/27/2024,NI,4453,4614,2993,4755,4114;4119,3221,4315,NA,0;17356253,6/18/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/05/2025 in a 90 year old Male. On 06/18/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Bleeding - Major could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 22 out of 1641 (1.3%) of subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,90,Male,90.7,3/5/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;9226759,Unknown Date,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,IN,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/27/2024 in a 78 year old Female. On an Unknown Date, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Myocardial Infarction could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Three out of 1641 (0.2%) of subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No information,78,Female,51.07,11/27/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;

Description of Event or Problem · 0

IT WAS REPORTED THROUGH STS/ACC TVT REGISTRY - TRICLIP DATA THAT TRICLIP DEVICES MAY BE RELATED TO 475 ADVERSE EVENTS WHICH ARE CONSIDERED SERIOUS INJURY INCLUDING: ATRIAL FIBRILLATION, BLEEDING - ACCESS SITE, BLEEDING - HEMATOMA AT ACCESS SITE, BLEEDING - LIFE THREATENING, BLEEDING - MAJOR, BLEEDING - OTHER, BLEEDING - RETROPERITONEAL, CARDIAC ARREST, CARDIAC SURGERY OR INTERVENTION - OTHER UNPLANNED, COMPLETE LEAFLET CLIP DETACHMENT, DEEP VEIN THROMBOSIS, DEVICE EMBOLIZATION, DIALYSIS (NEW REQUIREMENT), ICD, MECHANICAL SUPPORT, MYOCARDIAL INFARCTION, PCI, PERMANENT PACEMAKER, READMISSION - HEART FAILURE, READMISSION (VALVE RELATED), RECURRENT TRICUSPID REGURGITATION, REINTERVENTION - TRICUSPID VALVE, STROKE - ISCHEMIC, VASCULAR COMPLICATION - MAJOR, VASCULAR COMPLICATION - MINOR, VASCULAR SURGERY OR INTERVENTION - UNPLANNED, WORSENING TRICUSPID REGURGITATION, UNKNOWN ADVERSE EVENT. THE RELATIONSHIP OF THE MALFUNCTION TO THE TRICLIP DEVICES COULD NOT BE DETERMINED BASED ON THE LIMITED DATA RECEIVED FROM THE REGISTRY. STS/ACC TVT REGISTRY - TRICLIP DATA IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - RWD2400493. THE DATA RECEIVED INDICATED THAT THE PROCEDURE DATE RANGE WAS BETWEEN 02 APRIL 2024 ¿ 27 MARCH 2025. PATIENTS¿ MEAN AGE IS 78 YEARS, RANGING FROM 33 TO 101 YEARS. 43% OF THE PATIENTS WERE MALE, 57% OF THE PATIENTS WERE FEMALE. AS OF 27 MARCH 2025, 1641 PATIENTS WERE TREATED WITH THE TRICLIP SYSTEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1540735	TRICLIP DELIVERY SYSTEM (TCDS)	TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED	NPS	ABBOTT MEDICAL	UNKNOWN TCDS

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR	Female	Hospitalization| R

Terms

Patient problem · 14

• Arrhythmia
• Atrial Fibrillation
• Cardiac Arrest
• Embolism/Embolus
• Foreign Body In Patient
• Heart Failure/Congestive Heart Failure
• Hematoma
• Hemorrhage/Blood Loss/Bleeding
• Ischemia
• Myocardial Infarction
• Renal Failure
• Stroke/CVA
• Thrombosis/Thrombus
• Tricuspid Valve Insufficiency/ Regurgitation

Product problems · 2

• Adverse Event Without Identified Device or Use Problem
• Expulsion

Source type · 1

• Other

Type of report · 1

• Initial submission