TRICLIP DELIVERY SYSTEM (TCDS)
Report
- Report Number
- 2135147-2025-06250
- Event Type
- Malfunction
- Date Received
- October 30, 2025
- Date of Event
- May 23, 2024
- Report Date
- October 30, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPS
- PMA / PMN Number
- P230007
- Product Problem
- 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. 41 ADVERSE EVENTS THAT COULD BE RELATED TO THE TRICLIP DEVICE WERE REPORTED INCLUDING SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), UNKNOWN MALFUNCTION, INABILITY TO DEPLOY. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS LIMITED INFORMATION WAS PROVIDED INCLUDING THAT 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. H6. MEDICAL DEVICE PROBLEM CODE 3190 INSUFFICIENT INFORMATION WAS SELECTED AS LIMITED INFORMATION WAS PROVIDED FOR THE FOLLOWING EVENTS: DEVICE MALFUNCTION (UNKNOWN)/ OTHER (UNKNOWN).
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;9938670,5/23/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 05/23/2024 in a 74 year old Male. On 05/23/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,148.3,5/23/2024,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;8949028,7/10/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 07/10/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9941329,9/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 09/06/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9941329,9/6/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 09/06/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;42946680,3/26/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 03/26/2025, Device Malfunction (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Device Malfunction could not be determined based on the limited data received from the registry.","An event of Device Malfunction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Nine out of 1641 (0.5%) of subjects experienced Device Malfunction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;9413809,10/1/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/01/2024 in a 82 year old Male. On 10/01/2024, Device Malfunction (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Device Malfunction could not be determined based on the limited data received from the registry.","An event of Device Malfunction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Nine out of 1641 (0.5%) of subjects experienced Device Malfunction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,83.9,10/1/2024,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;9498285,10/9/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 10/09/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9497444,10/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/03/2024 in a 77 year old Male. On 10/03/2024, Device Malfunction (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Device Malfunction could not be determined based on the limited data received from the registry.","An event of Device Malfunction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Nine out of 1641 (0.5%) of subjects experienced Device Malfunction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,96,10/3/2024,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;9527008,10/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 10/17/2024, Device Malfunction (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Device Malfunction could not be determined based on the limited data received from the registry.","An event of Device Malfunction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Nine out of 1641 (0.5%) of subjects experienced Device Malfunction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;9582798,10/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 10/18/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;2833,10/26/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 10/26/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;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,M,"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, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;332232186,11/12/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/12/2024 in a 90 year old Male. On 11/12/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,60.9,11/12/2024,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;540990277,11/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 11/14/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;540990277,11/14/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 11/14/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9578737,11/19/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 11/19/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9804850,12/30/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 11/27/2024 in a 80 year old Male. On 12/30/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,64.2,11/27/2024,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9622348,12/4/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 12/04/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;887855,12/3/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/03/2024 in a 57 year old Female. On 12/03/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,Female,101.4,12/3/2024,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9254280,12/5/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/05/2024 in a 81 year old Female. On 12/05/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,72.1,12/5/2024,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;6451445,12/13/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/13/2024 in a 94 year old Male. On 12/13/2024, Device Malfunction (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Device Malfunction could not be determined based on the limited data received from the registry.","An event of Device Malfunction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Nine out of 1641 (0.5%) of subjects experienced Device Malfunction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,66,12/13/2024,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;8488,12/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/17/2024 in a 79 year old Female. On 12/17/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,48,12/17/2024,NI,4582,2199,2507,4755,4114;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,M,"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, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9693957,1/6/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/06/2025 in a 65 year old Female. On 01/06/2025, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,65,Female,69.9,1/6/2025,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;9799649,12/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 12/20/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;856352,2/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/13/2025 in a 78 year old Female. On 02/13/2025, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,121,2/13/2025,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;6717218,12/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/20/2024 in a 86 year old Female. On 12/20/2024, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,62.5,12/20/2024,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9714293,2/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 02/13/2025 in a 88 year old Female. On 02/13/2025, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,Female,63,2/13/2025,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;9622463,1/15/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 01/15/2025, Inability to Deploy the Valve was reported and is considered a Malfunction. The relationship of the Malfunction to the Inability to Deploy the Valve could not be determined based on the limited data received from the registry.","An event of Inability to Deploy the 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. Two out of 1641 (0.1%) of subjects experienced Inability to Deploy the 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,Female,93.4,1/15/2025,NI,4582,2199,3270,4755,4114;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,M,"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, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9717233,1/23/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 01/23/2025 in a 88 year old Female. On 01/23/2025, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,65,1/23/2025,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;3966089,3/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/12/2025 in a 83 year old Female. On 03/12/2025, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,83,Female,76.3,3/12/2025,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;9802778,3/13/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/13/2025 in a 52 year old Female. On 03/13/2025, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,56.7,3/13/2025,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;9923809,3/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/14/2025 in a 86 year old Male. On 03/14/2025, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,86,Male,65,3/14/2025,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;10065837,3/12/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/12/2025 in a 82 year old Female. On 03/12/2025, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,45.4,3/12/2025,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9762203,10/17/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 10/17/2024 in a 79 year old Female. On 10/17/2024, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,79,Female,50.2,10/17/2024,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;203853,12/18/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/18/2024 in a 83 year old Male. On 12/18/2024, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,83,Male,87.9,12/18/2024,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;2971,3/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 03/14/2025, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;2971,3/14/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"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 03/14/2025, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;9587512,12/20/2024,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 12/20/2024 in a 66 year old Male. On 12/20/2024, Other (Unknown) was reported and is considered a Malfunction. The relationship of the Malfunction to the Other (Unknown) could not be determined based on the limited data received from the registry.","An event of 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. 14 out of 1641 (0.9%) of subjects experienced 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,66,Male,78.9,12/20/2024,NI,4582,2199,3190,4755,4114;4119,3221,4315,NA,0;1012803,3/26/2025,10/30/2025,7/25/2025,TriClip G4 Delivery System (TCDS),"Tricuspid valve repair device, percutaneously delivered",TCDS0301,Unknown,TCDS0301,NI,NI,P230007,NA,M,"It was reported through STS/ACC TVT1 Registry data that a TriClip was implanted on 03/26/2025 in a 87 year old Male. On 03/26/2025, Single Leaflet Device Attachment was reported and is considered a Malfunction. The relationship of the Malfunction to the Single Leaflet Device Attachment could not be determined based on the limited data received from the registry.","An event of Single Leaflet Device Attachment was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 33 out of 1641 (2.0%) of subjects experienced Single Leaflet Device Attachment since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to 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,84,3/26/2025,NI,4582,2199,2507,4755,4114;4119,3221,4315,NA,0;
IT WAS REPORTED THROUGH STS/ACC TVT REGISTRY - TRICLIP DATA THAT TRICLIP DEVICES MAY BE RELATED TO 41 ADVERSE EVENTS WHICH ARE CONSIDERED MALFUNCTION INCLUDING: SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), UNKNOWN MALFUNCTION, INABILITY TO DEPLOY. 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 23 MAY 2024 ¿ 26 MARCH 2025. PATIENTS¿ MEAN AGE IS 77 YEARS, RANGING FROM 50 TO 94 YEARS. 51% OF THE PATIENTS WERE MALE, 49% 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 |
|---|---|---|---|---|---|---|---|
| 2297484 | 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 |