TRICLIP DELIVERY SYSTEM (TCDS)
Report
- Report Number
- 2135147-2025-06258
- Event Type
- Death
- Date Received
- October 30, 2025
- Date of Event
- September 16, 2024
- Report Date
- October 30, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPS
- PMA / PMN Number
- P230007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT IS FOR QUARTER 3 TIMEFRAME BETWEEN 01 JULY 2025 - 30 SEPTEMBER 2025. 36 ADVERSE EVENTS THAT COULD BE RELATED TO THE TRICLIP DEVICE WERE REPORTED INCLUDING CARDIOVASCULAR PROCEDURE, HEART FAILURE, HEPATOBILIARY, INFECTION, OTHER CARDIOVASCULAR REASON, OTHER NON-CARDIOVASCULAR REASON, PULMONARY, RENAL, STROKE, SUDDEN CARDIAC DEATH. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS LIMITED INFORMATION WAS PROVIDED INCLUDING THAT 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. B2. THE DATE OF DEATH USED IS THE EARLIEST DEATH DATE. 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.
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;7956707,9/16/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 09/16/2024, patient death was reported due to Cardiovascular procedure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Cardiovascular procedure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Cardiovascular procedure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,85,Female,69.4,9/9/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9542649,10/21/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 10/21/2024, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,65,Female,82,10/1/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9432507,11/1/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/09/2024 in a 72 year old Female. On 11/01/2024, patient death was reported due to Pulmonary. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Pulmonary was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Pulmonary since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,72,Female,59.55,10/9/2024,NI,2484,1802,2993,4755,4114;4119,3221,4315,NA,0;9698531,11/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 11/06/2024, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,84,Female,68.75,10/10/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9496302,11/11/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/23/2024 in a 82 year old Male. On 11/11/2024, patient death was reported due to Hepatobiliary. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Hepatobiliary was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Hepatobiliary since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,82,Male,113.5,10/23/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9475067,11/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 11/17/2024, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,80,Female,67.9,10/10/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;217871618,11/23/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/31/2024 in a 90 year old Male. On 11/23/2024, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,90,Male,73.6,10/31/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;201984,1/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 04/22/2024 in a 78 year old Male. On 01/12/2025, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,78,Male,82.7,4/22/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9508182,12/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 12/18/2024, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,86,Male,53.6,11/4/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9436252,12/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/15/2024 in a 72 year old Male. On 12/20/2024, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,72,Male,59.9,10/15/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;680810,12/24/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 12/24/2024, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,61,Female,93.1,10/16/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9113115,1/1/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/23/2024 in a 70 year old Male. On 01/01/2025, patient death was reported due to Infection. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Infection was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Infection since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,70,Male,64.8,5/23/2024,NI,1930,1802,2993,4755,4114;4119,3221,4315,NA,0;9598332,1/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 01/02/2025, patient death was reported due to Cardiovascular procedure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Cardiovascular procedure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Cardiovascular procedure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,76,Male,72.6,12/9/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9528529,1/4/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 01/04/2025, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,75,Male,104,11/18/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9077386,1/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/05/2024 in a 82 year old Male. On 01/05/2025, patient death was reported due to Other cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,82,Male,68.5,11/5/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;1305071,1/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 01/05/2025, patient death was reported due to Other cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,56,Female,74.9,12/17/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9398801,2/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/02/2025 in a 80 year old Female. On 02/06/2025, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,80,Female,66.2,1/2/2025,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9419276,2/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 02/06/2025, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,91,Female,68.7,1/16/2025,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;3950498,1/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/20/2024 in a 82 year old Male. On 01/17/2025, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,82,Male,79.9,12/20/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9202339,2/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 07/15/2024 in a 91 year old Female. On 02/14/2025, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,91,Female,54,7/15/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9622463,1/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/15/2025 in a 70 year old Female. On 01/28/2025, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,70,Female,93.4,1/15/2025,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9736288,3/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/05/2025 in a 59 year old Male. On 03/06/2025, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,59,Male,71.8,2/5/2025,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9991479,4/20/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/24/2025 in a 69 year old Male. On 04/20/2025, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,69,Male,85.3,2/24/2025,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;7868610,2/10/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 02/10/2025, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,81,Male,69.7,12/17/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;9473090,5/24/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 05/24/2025, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,84,Male,70.6,7/26/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9113809,2/19/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 02/19/2025, patient death was reported due to Stroke. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Stroke was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Stroke since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,92,Female,45.4,5/21/2024,NI,1770,1802,2993,4755,4114;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,D,"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, patient death was reported due to Cardiovascular procedure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Cardiovascular procedure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Cardiovascular procedure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,82,Male,68,2/26/2025,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;747412,12/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/20/2024 in a 58 year old Male. On 12/09/2024, patient death was reported due to Sudden cardiac death. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Six out of 1641 (0.4%) subjects experienced death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,58,Male,128,11/20/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9637432,1/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/09/2025 in a 63 year old Male. On 01/15/2025, patient death was reported due to Sudden cardiac death. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Six out of 1641 (0.4%) subjects experienced death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,63,Male,103.4,1/9/2025,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9716503,1/17/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 01/17/2025, patient death was reported due to Sudden cardiac death. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Six out of 1641 (0.4%) subjects experienced death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,80,Male,117.4,1/7/2025,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9378407,3/28/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 03/28/2025, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,81,Female,65,8/1/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;1597365,4/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 04/29/2024 in a 74 year old Male. On 04/05/2025, patient death was reported due to Heart failure. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 11 out of 1641 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,74,Male,118,4/29/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;6701314,4/5/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/14/2025 in a 72 year old Male. On 04/05/2025, patient death was reported due to Renal. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Renal was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on 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%) subjects experienced death due to Renal since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,72,Male,55.5,3/14/2025,NI,2041,1802,2993,4755,4114;4119,3221,4315,NA,0;505659120,3/2/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/10/2025 in a 79 year old Female. On 03/02/2025, patient death was reported due to Sudden cardiac death. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Six out of 1641 (0.4%) subjects experienced death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,79,Female,126,2/10/2025,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;9534613,3/27/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"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 03/27/2025, patient death was reported due to Sudden cardiac death. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Six out of 1641 (0.4%) subjects experienced death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,78,Male,53.8,3/6/2025,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;8299144,4/21/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,D,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 08/01/2024 in a 85 year old Male. On 04/21/2025, patient death was reported due to Sudden cardiac death. The relationship of the Death to the TriClip could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Six out of 1641 (0.4%) subjects experienced death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,85,Male,88,8/1/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;
IT WAS REPORTED THROUGH STS/ACC TVT REGISTRY - TRICLIP DATA THAT TRICLIP DEVICES MAY BE RELATED TO 36 ADVERSE EVENTS WHICH ARE CONSIDERED DEATH INCLUDING: CARDIOVASCULAR PROCEDURE, HEART FAILURE, HEPATOBILIARY, INFECTION, OTHER CARDIOVASCULAR REASON, OTHER NON-CARDIOVASCULAR REASON, PULMONARY, RENAL, STROKE, SUDDEN CARDIAC DEATH. 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 (B)(6) 2025. PATIENTS¿ MEAN AGE IS 77 YEARS, RANGING FROM 56 TO 92 YEARS. 61% OF THE PATIENTS WERE MALE, 39% OF THE PATIENTS WERE FEMALE. AS OF (B)(6) 2025, 1641 PATIENTS WERE TREATED WITH THE TRICLIP SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2407915 | TRICLIP DELIVERY SYSTEM (TCDS) | TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED | NPS | ABBOTT MEDICAL | UNKNOWN TCDS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Death |