EDWARDS INSPIRIS RESILIA AORTIC VALVE
Report
- Report Number
- 2015691-2025-07350
- Event Type
- Injury
- Date Received
- September 8, 2025
- Date of Event
- August 1, 2025
- Report Date
- October 16, 2025
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- UDI-DI
- 00690103194982
- PMA / PMN Number
- P150048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: ADDITIONAL MANUFACTURER NARRATIVE: ATTEMPTS HAVE BEEN MADE TO OBTAIN PRODUCT FOR EVALUATION. NO DEVICE WAS RETURNED. 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 SECTIONS G3, G6, H2, H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). ATTEMPTS HAVE BEEN MADE TO OBTAIN PRODUCT FOR EVALUATION. NO DEVICE WAS RETURNED. BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR REGURGITATION AND/OR STENOSIS. DUE DILIGENCE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING A DEVICE FAILURE MODE, HOWEVER ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME. PATIENT MEDICAL RECORDS WERE NOT PROVIDED BY THE HOSPITAL FOR REVIEW, OR THE MEDICAL RECORDS PROVIDED DO NOT CLARIFY THE DEVICE FAILURE MODE. IN THIS CASE, THERE IS NO EVIDENCE OF A MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON-CONFORMANCE AND/OR ONE WAS NOT SUSPECTED OR CONFIRMED THROUGH INVESTIGATION; NO LABELING NON-CONFORMANCE/DEFICIENCY; NO USE-RELATED ISSUE WITH A HAZARDOUS SITUATION; NO DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. PER THE INSTRUCTIONS FOR USE (IFU), REOPERATION/EXPLANT ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC CARDIAC VALVES AND ANNULOPLASTY RINGS. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS NO INFORMATION REGARDING A DEVICE FAILURE MODE WAS PROVIDED. THEREFORE, A REVIEW OF MANUFACTURING AND/OR DEVICE COMPONENT ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT IS UNABLE TO BE PERFORMED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE (3) YEARS, AND 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH 21MM 3300TFX AORTIC VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2168893 | EDWARDS INSPIRIS RESILIA AORTIC VALVE | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | EDWARDS LIFESCIENCES | 11500A | 00690103194982 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Hospitalization| L| R |