TRICLIP G4 SYSTEM
Report
- Report Number
- 2135147-2025-07390
- Event Type
- Death
- Date Received
- December 15, 2025
- Date of Event
- November 20, 2025
- Report Date
- March 4, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPS
- UDI-DI
- 05415067047755
- PMA / PMN Number
- P230007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED UNINTENDED MOVEMENT OR DIFFICULT TO REMOVE (CDS/SGC, ANATOMY). ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. THE CASE WAS REVIEWED BY AN ABBOTT SENIOR DIRECTOR OF MEDICAL AFFAIRS. BASED ON AVAILABLE INFORMATION, CAUSES FOR THE REPORTED UNINTENDED MOVEMENT AND DIFFICULT REMOVAL OF THE TCDS THROUGH THE TSGC COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED DIFFICULT REMOVAL FROM ANATOMY APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS (CLIP CAUGHT ON ANATOMY). THE REPORTED CARDIAC TAMPONADE, PERICARDIAL EFFUSION, TISSUE INJURY, AND DEATH WERE CASCADING EVENTS OF THE DIFFICULT REMOVAL FROM ANATOMY. THE REPORTED PATIENT EFFECTS OF CARDIAC TAMPONADE, PERICARDIAL EFFUSION, TISSUE INJURY, AND DEATH, AS LISTED IN THE TRICLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH TRICLIP PROCEDURES. THE REPORTED HOSPITALIZATION, SURGICAL INTERVENTION, UNEXPECTED MEDICAL INTERVENTIONS, AND MEDICATION REQUIRED WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.
B5. CORRECTION: UPDATED PROCEDURE DESCRIPTION INCLUDES THE MEDSUN AND MEDWATCH REFERENCE NUMBERS ASSOCIATED WITH THE REPORTED EVENT. G2. REPORT SOURCE CORRECTION: INCLUDED USER FACILITY. H10. CORRECTION: UPDATED TO INCLUDE THE REFERENCE NUMBERS: USER FACILITY/IMPORTER MEDSUN REPORT NUMBER (B)(4) AND USER FACILITY MEDWATCH REPORT MW5179484. H10. CORRECTION: UPDATED TO INCLUDE RELATED MANUFACTURER REPORT NUMBER: 2135147-2025-07391.
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
N/A.
USER FACILITY MEDWATCH REPORT MW5179484 RECEIVED THAT STATES "DEATH OCCURRED DURING AN ELECTIVE TRICUSPID TRANSCATHETER EDGE TO EDGE REPAIR USING A TRICLIP G4, XTW DEVICE, DUE TO AN INTRAOPERATIVE TEAR OF HEART AND VENA CAVA. THE DEVICE WAS REPORTEDLY ADVANCED INTO THE RIGHT ATRIUM AND DIRECTED TOWARD THE TRICUSPID VALVE, AT WHICH TIME IT BECAME "CAUGHT UNDERNEATH" THE TRICUSPID VALVE APPARATUS AND THUS WAS NOT EXTENDED OPEN. INSTEAD, THE DEVICE WAS REPORTEDLY RETRACTED INTO THE RIGHT ATRIUM AND RE-SHEATHED. IT IS REPORTED THAT AS SOON AS THE DEVICE WAS PULLED INTO THE INFERIOR VENA CAVA, A LARGE PERICARDIAL EFFUSION WITH TAMPONADE DEVELOPED. AUTOPSY REVEALED MYOCARDIAL ABRASIONS AND A TORN CHORDA TENDINEA WHERE THE DEVICE BECAME TANGLED IN THE TRICUSPID VALVE AND A LARGE TEAR OF THE RIGHT ATRIAL WALL EXTENDING INTO THE INFERIOR VENA CAVA. THE TRICLIP WAS DISCARDED BY THE HOSPITAL WITHOUT EXAMINATION. CLINICAL DIAGNOSIS OF SEVERE TRICUSPID REGURGITATION. AUTOPSY FINDING OF FOCAL THICKENING OF ANTERIOR TRICUSPID LEAFLET." UF/IMPORTER MEDSUN REPORT NUMBER (B)(4) RECEIVED THAT STATES "DESCRIBE THE EVENT OR PROBLEM: AFTER ADDED FLEX, IT WAS APPARENT THAT THE DEVICE WAS ALREADY UNDERNEATH THE TRICUSPID VALVE IN THE ANTEROSEPTAL COMMISSURE. AT THIS POINT, WE HAD NOT ADVANCED THE CLIP DELIVERY SYSTEM AT ALL. IT BECAME CLEAR THAT THEY WOULD NOT HAVE BEEN ENOUGH HEIGHT ABOVE THE TRICUSPID VALVE FOR US TO SUCCESSFULLY PERFORM THE PROCEDURE. WE TRIED TO RETRIEVE THE SYSTEM. THE SYSTEM APPEARED TO BE CAUGHT UNDERNEATH THE TRICUSPID VALVE APPARATUS. WITH SOME RETRACTION OF THE GUIDE CATHETER, WE WERE ABLE TO RETRIEVE THE DEVICE INTO THE RIGHT ATRIUM. WE THEN TRIED TO RE-SHEATH THE TRICUSPID CLIP DEVICE INTO THE GUIDE CATHETER AND PULLED THE SYSTEM INTO THE IVC [INFERIOR VENA CAVA]. AS SOON AS WE RETRACTED THE DEVICE INTO THE IVC, THERE WAS A NEW LARGE PERICARDIAL EFFUSION RESULTING IN PERICARDIAL TAMPONADE. THE PATIENT HAD HEMODYNAMIC COMPROMISE AT THAT POINT. WE PERFORMED EMERGENT PERICARDIOCENTESIS. THERE CONTINUE TO BE ONGOING EXTRAVASATION OF BLOOD, AND SHE CONTINUED TO BECOME HEMODYNAMICALLY UNSTABLE. WE CALLED CARDIAC SURGERY FOR CONSULTATION. DOCTOR MADE THE DECISION TO OPEN THE PATIENT TO TRY IDENTIFYING AND REPAIR THE INJURY. WITH ONGOING CPR, EMERGENT STERNOTOMY WAS PERFORMED. CARDIAC EXPLORATION SHOWED THE LOCATION OF TEAR TO BE IN THE IVC. THE TRI CLIP GUIDE CATHETER WAS REMOVED, AND THE DEVICE WAS EXCHANGED WITH A 22 FRENCH DRY SEAL. A 20 FRENCH SHEATH WAS INSERTED IN THE LEFT FEMORAL VEIN. UNFORTUNATELY, THE PATIENT CONTINUED TO BLEED AND WAS INTRAVASCULARLY VOLUME DEPLETED. MASSIVE TRANSFUSION PROTOCOL WAS GIVEN VIA BIFEMORAL SHEATHS. CONTINUOUS CARDIAC MASSAGE WAS PERFORMED WHILE DOCTOR WAS TRYING TO REPAIR THE IVC INJURY. A TOTAL OF 45 MINUTES OF ATTEMPT TO RESUSCITATE AND CONTROL THE BLEEDING WERE PERFORMED. HOWEVER, THE PATIENT NEVER REGAINED A PULSE AND WAS ULTIMATELY PRONOUNCED DEAD AT APPROXIMATELY 2 PM." IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4 AND A SHORTENED RIGHT ATRIUM. A TRICLIP XTW WAS INSERTED AND STEERED DOWN TO THE VALVE. HOWEVER, THE CLIP WAS POSITIONED TOO FAR BELOW THE LEAFLET. THEREFORE, THE CLIP WAS MANEUVERED TO GAIN HEIGHT. A DECISION WAS MADE TO REMOVE THE CLIP AND ATTEMPT LEFT GROIN ACCESS. HOWEVER, WHILE ATTEMPTING TO REMOVE THE CLIP DELIVERY SYSTEM (CDS) INTO THE GUIDE, RESISTANCE WAS ENCOUNTERED. IT WAS NOTED THAT THE CLIP WAS TRAPPED UNDERNEATH THE TRICUSPID VALVE APPARATUS. TROUBLESHOOTING WAS PERFORMED, AND THE CLIP WAS ABLE TO BE RETRIEVED INTO THE RIGHT ATRIUM. WHILE RE-SHEATHING THE TRICLIP XTW INTO THE STEERABLE GUIDE CATHETER (SGC), THE SYSTEM WAS PULLED INTO THE INFERIOR VENA CAVA (IVC). HOWEVER, AS SOON AS THE DEVICE WAS RETRACTED INTO THE IVC, IT WAS NOTED THAT THE CLIP SUDDENLY MOVED, AND A PERICARDIAL EFFUSION WAS OBSERVED. IT WAS NOTED THAT THE PATIENT WAS HEMODYNAMICALLY COMPROMISED AT THAT POINT. TO TREAT THE PERICARDIAL EFFUSION, AN EMERGENT PERICARDIOCENTESIS WAS PERFORMED. HOWEVER, THE PERICARDIAL EFFUSION PERSISTED. IT WAS NOTED THAT ONGOING EXTRAVASATION OF BLOOD CONTINUED, AND THE PATIENT CONTINUED TO BE HEMODYNAMICALLY UNSTABLE. A CARDIAC SURGEON WAS CALLED TO THE BEDSIDE, WITH ONGOING CARDIOPULMONARY RESUSCITATION (CPR), EMERGENT STERNOTOMY WAS PERFORMED. CARDIAC EXPLORATION SHOWED THE LOCATION OF TEAR TO BE IN THE IVC. THE TRICLIP GUIDE CATHETER WAS REMOVED, AND THE DEVICE WAS EXCHANGED WITH A 22 FRENCH DRY SEAL. A 20 FRENCH SHEATH WAS INSERTED IN THE LEFT FEMORAL VEIN. IT WAS NOTED THAT THE PATIENT CONTINUED TO BLEED AND WAS INTRAVASCULARLY VOLUME DEPLETED. MASSIVE TRANSFUSION PROTOCOL WAS GIVEN VIA BIFEMORAL SHEATHS. CONTINUOUS CARDIAC MASSAGE WAS PERFORMED WHILE THE PHYSICIAN WAS TRYING TO REPAIR THE IVC INJURY. A TOTAL OF 45 MINUTES OF ATTEMPTS TO RESUSCITATE AND CONTROL THE BLEEDING WERE PERFORMED. AN ATTEMPT TO PLACE THE PATIENT ON BYPASS WAS PERFORMED, BUT DUE TO AN IVC TEAR, THE PATIENT WAS UNABLE TO BE PLACED ON BYPASS. THE PATIENT ULTIMATELY PASSED AWAY THE SAME DAY. CLINICAL DIAGNOSIS OF SEVERE TRICUSPID REGURGITATION WAS NOTED AND AUTOPSY FINDING INCLUDED FOCAL THICKENING OF ANTERIOR TRICUSPID LEAFLET WERE REPORTED.
IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4 AND A SHORTENED RIGHT ATRIUM. A TRICLIP XTW WAS INSERTED AND STEERED DOWN TO THE VALVE. HOWEVER, THE CLIP WAS POSITIONED TOO FAR BELOW THE LEAFLET. THEREFORE, THE CLIP WAS MANEUVERED TO GAIN HEIGHT. A DECISION WAS MADE TO REMOVE THE CLIP AND ATTEMPT LEFT GROIN ACCESS. HOWEVER, WHILE ATTEMPTING TO REMOVE THE CLIP DELIVERY SYSTEM (CDS) INTO THE GUIDE, RESISTANCE WAS ENCOUNTERED. THE CLIP SUDDENLY MOVED, AND A PERICARDIAL EFFUSION WAS OBSERVED. TO TREAT THE PERICARDIAL EFFUSION, A PERICARDIOCENTESIS WAS PERFORMED. HOWEVER, THE PERICARDIAL EFFUSION PERSISTED. A CARDIAC SURGEON WAS CALLED TO THE BEDSIDE, AND THE PATIENT¿S CHEST CAVITY WAS OPENED. AN ATTEMPT TO PLACE THE PATIENT ON BYPASS WAS PERFORMED, BUT DUE TO AN INFERIOR VENA CAVA (IVC) TEAR, THE PATIENT WAS UNABLE TO BE PLACED ON BYPASS. HEROIC MEASURES WERE ATTEMPTED, BUT WITHOUT SUCCESS. THE PATIENT ULTIMATELY PASSED AWAY. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: AFTER ADDING FLEX, IT WAS APPARENT THAT THE TRICLIP XTW CLIP WAS UNDERNEATH THE TRICUSPID VALVE IN THE ANTEROSEPTAL COMMISSURE. IT WAS NOTED THAT THE CLIP DELIVERY SYSTEM WAS NOT YET ADVANCED. IT WAS NOTED THAT IT BECAME CLEAR THAT THERE WAS NOT ENOUGH HEIGHT ABOVE THE TRICUSPID VALVE TO SUCCESSFULLY PERFORM THE PROCEDURE. THEREFORE, A DECISION WAS MADE TO REMOVE THE CLIP. HOWEVER, WHILE ATTEMPTING TO REMOVE THE CLIP, IT WAS OBSERVED THAT THE CLIP WAS CAUGHT UNDERNEATH THE TRICUSPID VALVE APPARATUS. TROUBLESHOOTING WAS PERFORMED, AND THE CLIP WAS ABLE TO BE RETRIEVED INTO THE RIGHT ATRIUM. WHILE RE-SHEATHING THE TRICLIP XTW INTO THE STEERABLE GUIDE CATHETER (SGC), THE SYSTEM WAS PULLED INTO THE INFERIOR VENA CAVA (IVC). HOWEVER, AS SOON AS THE DEVICE WAS RETRACTED INTO THE IVC, THERE WAS A NEW LARGE PERICARDIAL EFFUSION, RESULTING IN PERICARDIAL TAMPONADE. IT WAS NOTED THAT THE PATIENT WAS HEMODYNAMICALLY COMPROMISED AT THAT POINT. THEREFORE, AN EMERGENT PERICARDIOCENTESIS WAS PERFORMED. IT WAS NOTED THAT ONGOING EXTRAVASATION OF BLOOD CONTINUED, AND THE PATIENT CONTINUED TO BE HEMODYNAMICALLY UNSTABLE. CARDIAC SURGERY WAS THEN CONSULTED. WITH ONGOING CARDIOPULMONARY RESUSCITATION (CPR), EMERGENT STERNOTOMY WAS PERFORMED. CARDIAC EXPLORATION SHOWED THE LOCATION OF TEAR TO BE IN THE IVC. THE TRI CLIP GUIDE CATHETER WAS REMOVED, AND THE DEVICE WAS EXCHANGED WITH A 22 FRENCH DRY SEAL. A 20 FRENCH SHEATH WAS INSERTED IN THE LEFT FEMORAL VEIN. IT WAS NOTED THAT THE PATIENT CONTINUED TO BLEED AND WAS INTRAVASCULARLY VOLUME DEPLETED. MASSIVE TRANSFUSION PROTOCOL WAS GIVEN VIA BIFEMORAL SHEATHS. CONTINUOUS CARDIAC MASSAGE WAS PERFORMED WHILE DOCTOR WAS TRYING TO REPAIR THE IVC INJURY. A TOTAL OF 45 MINUTES OF ATTEMPT TO RESUSCITATE AND CONTROL THE BLEEDING WERE PERFORMED. HOWEVER, THE PATIENT NEVER REGAINED A PULSE AND WAS ULTIMATELY PRONOUNCED DEAD AT APPROXIMATELY 2 PM.
IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4 AND A SHORTENED RIGHT ATRIUM. A TRICLIP XTW WAS INSERTED AND STEERED DOWN TO THE VALVE. HOWEVER, THE CLIP WAS POSITIONED TOO FAR BELOW THE LEAFLET. THEREFORE, THE CLIP WAS MANEUVERED TO GAIN HEIGHT. A DECISION WAS MADE TO REMOVE THE CLIP AND ATTEMPT LEFT GROIN ACCESS. HOWEVER, WHILE ATTEMPTING TO REMOVE THE CLIP DELIVERY SYSTEM (CDS) INTO THE GUIDE, RESISTANCE WAS ENCOUNTERED. THE CLIP SUDDENLY MOVED, AND A PERICARDIAL EFFUSION WAS OBSERVED. TO TREAT THE PERICARDIAL EFFUSION, A PERICARDIOCENTESIS WAS PERFORMED. HOWEVER, THE PERICARDIAL EFFUSION PERSISTED. A CARDIAC SURGEON WAS CALLED TO THE BEDSIDE, AND THE PATIENT¿S CHEST CAVITY WAS OPENED. AN ATTEMPT TO PLACE THE PATIENT ON BYPASS WAS PERFORMED, BUT DUE TO AN INFERIOR VENA CAVA (IVC) TEAR, THE PATIENT WAS UNABLE TO BE PLACED ON BYPASS. HEROIC MEASURES WERE ATTEMPTED, BUT WITHOUT SUCCESS. THE PATIENT ULTIMATELY PASSED AWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140639 | TRICLIP G4 SYSTEM | TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED | NPS | ABBOTT MEDICAL | TCDS0301-XTW | 50820R1083 | 05415067047755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Unknown | Required Intervention| O| H| D | STEERABLE GUIDE CATHETER. |