P150048
Report
- Report Number
- 2015691-2025-07931
- Event Type
- Injury
- Date Received
- September 26, 2025
- Date of Event
- September 3, 2025
- Report Date
- November 11, 2025
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P150048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: ADDITIONAL MANUFACTURER NARRATIVE: THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.
H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED: B4, G3, G6, H2, H6. DEHISCENCE REFERS TO THE SEPARATION OF THE PROSTHETIC VALVE FROM THE SURROUNDING HEART TISSUE, TYPICALLY AT THE SEWING RING WHERE THE VALVE IS SUTURED TO THE ANNULUS. THIS SEPARATION CAN CAUSE BLOOD TO LEAK AROUND THE VALVE (PARAVALVULAR REGURGITATION), REDUCING ITS EFFECTIVENESS AND STRAINING THE HEART. THIS GENERALLY OCCURS DUE TO PATIENT-RELATED ANATOMICAL FACTORS, SUCH AS IRREGULAR ANATOMY, WHICH MAY LEAD TO INCREASED STRESS ON THE SURROUNDING TISSUE OVER TIME. THIS IS OFTEN AS A RESULT OF SUCCESSIVE DILATION OF CARDIAC STRUCTURES CAUSED BY PROGRESSIONS OF VALVULAR DISEASE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS NO S/N WAS PROVIDED. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE IS PATIENT FACTORS.
H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED: B4, B5, B7, G3, G6, H2, H6.
IT WAS REPORTED THAT A PATIENT WITH A 29MM 11500A INSPIRIS VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN UNKNOWN IMPLANT DURATION DUE TO DEHISCENCE THAT RESULTED BLOOD FLOW INTO PSEUDOANEURYSM. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THERE WAS NO PATIENT INJURY.
IT WAS REPORTED THAT A PATIENT WITH A 29MM 11500A INSPIRIS VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN UNKNOWN IMPLANT DURATION DUE TO DEHISCENCE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2124822 | P150048 | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | EDWARDS LIFESCIENCES | 11500A29 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Life Threatening| H| R |