EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM
Report
- Report Number
- 2015691-2024-05138
- Event Type
- Injury
- Date Received
- July 3, 2024
- Date of Event
- June 10, 2024
- Report Date
- August 5, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPW
- UDI-DI
- 00690103217469
- PMA / PMN Number
- P230013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED/ADDED: B4, B5, G3, G6, H2 AND H11.
THE EVENT IS CAPTURED BY EDWARDS LIFESCIENCES UNDER COMPLAINT #: (B)(4). THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
THE COMPLAINT FOR VALVE DEPLOYED TOO VENTRICULAR POSITION WAS CONFIRMED WITH OBJECTIVE EVIDENCE WITH THE PROVIDED IMAGES. NO MANUFACTURING OR FUNCTIONAL NON-CONFORMITIES WERE FOUND OR IDENTIFIED FROM THE IMAGING EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT THE PROCEDURAL, PATIENT RELATED, AND IMAGING ISSUES MAY HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT FOR DELIVERY SYSTEM INTERACTS WITH IMPLANT DURING DEVICE REMOVAL WAS CONFIRMED WITH EMPIRICAL EVIDENCE WITH THE DESCRIPTION FROM THE CLINICAL SPECIALIST. NO MANUFACTURING OR FUNCTIONAL NON-CONFORMITIES WERE FOUND OR IDENTIFIED FROM THE IMAGING EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT NOT CENTRALIZING THE DELIVERY SYSTEM WITHIN THE VALVE DURING DELIVERY SYSTEM REMOVAL MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED SINCE NO FLUOROSCOPY IMAGES WERE PROVIDED.
ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SPECIALIST STATED THAT THE DEVICE APPEARED TO BE IN A PERFECT POSITION FOR DEPLOYMENT, NO ISSUES WERE EXPECTED. AFTER THE DEVICE WAS RELEASED FROM THE DELIVERY SYSTEM, THE ANTERIOR SIDE IMMEDIATELY FELL INTO THE RIGHT VENTRICLE. THIS IMMEDIACY IS WHAT MADE THE TEAM SUSPECT INTERACTION WITH SUBVALVULAR ANATOMY. PATIENT RECEIVED A SAPIEN VALVE IN VALVE TO PREVENT FURTHER MIGRATION INTO THE RIGHT VENTRICLE. THE PATIENT WAS RELEASED HOME THE FOLLOWING DAY.
EDWARDS RECEIVED NOTIFICATION OF AN EVOQUE IN TRICUSPID POSITION WHERE THE PATIENT WAS SIZED AND TREATED WITH 52MM EVOQUE. IT WAS DIFFICULT VISUALIZATION OF THE SEPTAL LEAFLET DUE TO THE INTERATRIAL SEPTUM SHADOWING. THE SEPTAL LEAFLET WAS PINNED, AND THE PINNING WAS CONFIRMED ON ICE IMAGING. MULTIPLE MANEUVERS WERE ATTEMPTED TO UNPIN THE SEPTAL LEAFLET WITHOUT ABILITY TO FULLY UNPIN MID SEPTAL. THE DEVICE WAS DEPLOYED AND IMMEDIATELY MIGRATED VENTRICULAR ON ANTERIOR/SEPTAL ASPECT OF VALVE. THERE WAS SOME INTERACTION WITH THE DELIVERY SYSTEM UPON REMOVAL. THE VALVE SHOWED BOTH DIASTOLIC AND SYSTOLIC FLOW AROUND VALVE IN THE ANTERO-SEPTAL REGION WITH ROCKING OF VALVE LEADING TO QUESTION OF OVERALL STABILITY. IT WAS DECIDED TO SNARE THE EVOQUE AND PERFORM A VALVE IN VALVE WITH THE SAPIEN 29MM DEVICE. WITH SNARE IN PLACE, THE SAPIEN WAS NAVIGATED ACROSS THE EVOQUE VALVE. SNARE WAS RELEASED AND SAPIEN WAS DEPLOYED SUCCESSFULLY WITHIN THE EVOQUE VALVE. FINAL VALVES APPEAR STABLE WITH MILD PARAVALVULAR LEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1283003 | EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM | PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES | NPW | EDWARDS LIFESCIENCES | 9850EV52US | 00690103217469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |