TRICLIP DELIVERY SYSTEM (TCDS)
Report
- Report Number
- 2135147-2025-07702
- Event Type
- Death
- Date Received
- December 24, 2025
- Date of Event
- August 1, 2020
- Report Date
- January 27, 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 DEVICE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING CORONARY ARTERY DISEASE, HYPERTENSION, ATRIAL FIBRILLATION, DIABETES MELLITUS, PERIPHERAL ARTERY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, TRICUSPID REGURGITATION, AND HEART FAILURE. COMPLICATIONS REPORTED INCLUDED DEATH, HEART FAILURE, BLEEDING, UNEXPECTED MEDICAL INTERVENTION (BLOOD TRANSFUSION), HOSPITALIZATION OR PROLONGED HOSPITALIZATION; 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: RIGHT ATRIAL PRESSURE CORRECTED CARDIAC POWER INDEX IMPROVES PREDICTIVE POWER FOR 1-YEAR MORTALITY AFTER TRANSCATHETER EDGE-TO-EDGE-REPAIR FOR SEVERE TRICUSPID VALVE REGURGITATION 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 ATTACHMENT: RIGHT ATRIAL PRESSURE CORRECTED CARDIAC POWER INDEX IMPROVES PREDICTIVE POWER FOR 1-YEAR MORTALITY AFTER TRANSCATHETER EDGE-TO-EDGE-REPAIR FOR SEVERE TRICUSPID VALVE REGURGITATION B2: DEATH DATE WAS ESTIMATED. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
THE ARTICLE, "RIGHT ATRIAL PRESSURE CORRECTED CARDIAC POWER INDEX IMPROVES PREDICTIVE POWER FOR 1-YEAR MORTALITY AFTER TRANSCATHETER EDGE-TO-EDGE-REPAIR FOR SEVERE TRICUSPID VALVE REGURGITATION", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE IMPACT OF RIGHT ATRIAL PRESSURE-CORRECTED CARDIAC POWER INDEX (CPIRAP) ON OUTCOMES IN PATIENTS WITH SEVERE TRICUSPID REGURGITATION UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER). THE DEVICES INCLUDED IN THIS STUDY WERE TRICLIP AND PASCAL. THE ARTICLE CONCLUDED THAT CPIRAP IS A ROBUST PREDICTOR OF OUTCOMES IN PATIENTS UNDERGOING T-TEER FOR SEVERE TRICUSPID REGURGITATION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ULRICH HANSES, BREMEN INSTITUTE FOR HEART AND CIRCULATION RESEARCH (BIHKF), AFFILIATED INSTITUTE TO THE UNIVERSITY OF LÜBECK, SENATOR-WESSLING-STR. 2, 28277 BREMEN, GERMANY, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED ALL PATIENTS WITH SEVERE TRICUSPID REGURGITATION UNDERGOING T-TEER FROM 01 AUGUST 2020 TO 30 JUNE 2023. A TOTAL OF 107 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 97% (104) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81 YEARS. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE, HYPERTENSION, ATRIAL FIBRILLATION, DIABETES MELLITUS, PERIPHERAL ARTERY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, TRICUSPID REGURGITATION, AND HEART FAILURE.
THE ARTICLE, "RIGHT ATRIAL PRESSURE CORRECTED CARDIAC POWER INDEX IMPROVES PREDICTIVE POWER FOR 1-YEAR MORTALITY AFTER TRANSCATHETER EDGE-TO-EDGE-REPAIR FOR SEVERE TRICUSPID VALVE REGURGITATION", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE IMPACT OF RIGHT ATRIAL PRESSURE-CORRECTED CARDIAC POWER INDEX (CPIRAP) ON OUTCOMES IN PATIENTS WITH SEVERE TRICUSPID REGURGITATION UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER). THE DEVICES INCLUDED IN THIS STUDY WERE TRICLIP AND PASCAL. THE ARTICLE CONCLUDED THAT CPIRAP IS A ROBUST PREDICTOR OF OUTCOMES IN PATIENTS UNDERGOING T-TEER FOR SEVERE TRICUSPID REGURGITATION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ULRICH HANSES, BREMEN INSTITUTE FOR HEART AND CIRCULATION RESEARCH (BIHKF), AFFILIATED INSTITUTE TO THE UNIVERSITY OF LÜBECK, SENATOR-WESSLING-STR. 2, 28277 BREMEN, GERMANY, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED ALL PATIENTS WITH SEVERE TRICUSPID REGURGITATION UNDERGOING T-TEER FROM 01 AUGUST 2020 TO 30 JUNE 2023. A TOTAL OF 107 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 97% (104) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81 YEARS. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE, HYPERTENSION, ATRIAL FIBRILLATION, DIABETES MELLITUS, PERIPHERAL ARTERY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, TRICUSPID REGURGITATION, AND HEART FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1918509 | 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 |