TRICLIP DELIVERY SYSTEM (TCDS)
Report
- Report Number
- 2135147-2025-07729
- Event Type
- Death
- Date Received
- December 24, 2025
- Date of Event
- January 1, 2021
- Report Date
- January 28, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPS
- PMA / PMN Number
- P230007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRICLIP WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, ARTERIAL HYPERTENSION, ATRIAL FIBRILLATION, TRICUSPID REGURGITATION, MITRAL REGURGITATION, AND PRIOR PERCUTANEOUS CORONARY INTERVENTION, AND CORONARY ARTERY BYPASS GRAFT. COMPLICATIONS REPORTED INCLUDED DEATH; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. LITERATURE ATTACHMENT: DETERMINANTS OF RECOVERY FROM RIGHT VENTRICULAR DYSFUNCTION AFTER TRANSCATHETER EDGE-TO-EDGE TRICUSPID VALVE REPAIR. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE: DETERMINANTS OF RECOVERY FROM RIGHT VENTRICULAR DYSFUNCTION AFTER TRANSCATHETER EDGE-TO-EDGE TRICUSPID VALVE REPAIR B3: EVENT DATE WAS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
THE ARTICLE, "DETERMINANTS OF RECOVERY FROM RIGHT VENTRICULAR DYSFUNCTION AFTER TRANSCATHETER EDGE-TO-EDGE TRICUSPID VALVE REPAIR", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE PREDICTORS OF RIGHT VENTRICULAR DYSFUNCTION (RVD) RECOVERY AFTER TRANSCATHETER EDGE-TO-EDGE TRICUSPID VALVE REPAIR (T-TEER). THE DEVICES INCLUDED IN THE STUDY WERE TRICLIP AND PASCAL. THE ARTICLE CONCLUDED THAT RECOVERY FROM RVD WAS MORE PREVALENT IN PATIENTS WHO PRESENTED WITH MILD RVD AND A SUFFICIENT REDUCTION IN TRICUSPID VALVE REGURGITATION TO MILD SEVERITY ACCORDING TO T-TEER. [THE PRIMARY AND CORRESPONDING AUTHOR WAS FELIX AUSBUETTEL, DEPARTMENT OF CARDIOLOGY, UNIVERSITY HOSPITAL MARBURG, PHILIPPS-UNIVERSITY MARBURG, MARBURG, GERMANY, WITH CORRESPONDING E-MAIL: [email protected].]. THIS STUDY INCLUDED ALL PATIENTS WHO UNDERWENT T-TEER FROM 01 JANUARY 2021 AND 31 DECEMBER 2023. A TOTAL OF 105 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81 YEARS. THE MAJORITY FENDER WAS FEMALE. COMORBIDITIES INCLUDED HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, ARTERIAL HYPERTENSION, ATRIAL FIBRILLATION, TRICUSPID REGURGITATION, MITRAL REGURGITATION, AND PRIOR PERCUTANEOUS CORONARY INTERVENTION, AND CORONARY ARTERY BYPASS GRAFT.
THE ARTICLE, "DETERMINANTS OF RECOVERY FROM RIGHT VENTRICULAR DYSFUNCTION AFTER TRANSCATHETER EDGE-TO-EDGE TRICUSPID VALVE REPAIR", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE PREDICTORS OF RIGHT VENTRICULAR DYSFUNCTION (RVD) RECOVERY AFTER TRANSCATHETER EDGE-TO-EDGE TRICUSPID VALVE REPAIR (T-TEER). THE DEVICES INCLUDED IN THE STUDY WERE TRICLIP AND PASCAL. THE ARTICLE CONCLUDED THAT RECOVERY FROM RVD WAS MORE PREVALENT IN PATIENTS WHO PRESENTED WITH MILD RVD AND A SUFFICIENT REDUCTION IN TRICUSPID VALVE REGURGITATION TO MILD SEVERITY ACCORDING TO T-TEER. [THE PRIMARY AND CORRESPONDING AUTHOR WAS FELIX AUSBUETTEL, DEPARTMENT OF CARDIOLOGY, UNIVERSITY HOSPITAL MARBURG, PHILIPPS-UNIVERSITY MARBURG, MARBURG, GERMANY, WITH CORRESPONDING E-MAIL: [email protected].]. THIS STUDY INCLUDED ALL PATIENTS WHO UNDERWENT T-TEER FROM 01 JANUARY 2021 AND 31 DECEMBER 2023. A TOTAL OF 105 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81 YEARS. THE MAJORITY FENDER WAS FEMALE. COMORBIDITIES INCLUDED HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, ARTERIAL HYPERTENSION, ATRIAL FIBRILLATION, TRICUSPID REGURGITATION, MITRAL REGURGITATION, AND PRIOR PERCUTANEOUS CORONARY INTERVENTION, AND CORONARY ARTERY BYPASS GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 765052 | TRICLIP DELIVERY SYSTEM (TCDS) | TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED | NPS | ABBOTT MEDICAL | UNKNOWN TCDS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |