EDWARDS INSPIRIS RESILIA AORTIC VALVE
Report
- Report Number
- 2015691-2024-09806
- Event Type
- Injury
- Date Received
- December 19, 2024
- Report Date
- February 19, 2026
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P150048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDED INFORMATION TO B5, B6, B7, G2, AND H6. FULL CITATION: KITANO T, TANIGUCHI T, EHARA N, NAKANE T, ESAKI J, FURUKAWA Y. EMERGENT TRANSCAROTID TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION IN DEGENERATIVE INSPIRIS RESILIA AORTIC VALVE. CARDIOVASC INTERV THER. 2025 DEC 3. DOI: 10.1007/S12928-025-01212-8. EPUB AHEAD OF PRINT. PMID: 41335392.
THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. 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 EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.
CALCIFIC DEGENERATION INVOLVES THE GRADUAL ACCUMULATION OF CALCIUM DEPOSITS ON THE VALVE LEAFLETS. IT IS A DISEASE CONTINUUM FROM SCLEROSIS TO CHRONIC INFLAMMATION THAT LEADS TO LEAFLET CALCIFICATION. THESE CALCIUM DEPOSITS, OVER TIME, CAUSE THE LEAFLETS TO BECOME RIGID AND LESS FLEXIBLE, WHICH CAN ACCOUNT FOR FAILURE MODES SUCH AS STENOSIS AND REGURGITATION. SVD IS A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BHV IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION. A DHR REVIEW IS UNABLE TO BE PERFORMED BECAUSE NO LOT/SERIAL NUMBER WAS PROVIDED. THERE IS NO ALLEGATION 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. THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING DIALYSIS.
ADDED INFORMATION TO H6. CALCIFIC DEGENERATION INVOLVES THE GRADUAL ACCUMULATION OF CALCIUM DEPOSITS ON THE VALVE LEAFLETS. IT IS A DISEASE CONTINUUM FROM SCLEROSIS TO CHRONIC INFLAMMATION THAT LEADS TO LEAFLET CALCIFICATION. THESE CALCIUM DEPOSITS, OVER TIME, CAUSE THE LEAFLETS TO BECOME RIGID AND LESS FLEXIBLE, WHICH CAN ACCOUNT FOR FAILURE MODES SUCH AS STENOSIS AND REGURGITATION. SVD IS A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BHV IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARD TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. A DHR REVIEW IS UNABLE TO BE PERFORMED BECAUSE SERIAL NUMBER REMAINS UNKNOWN. THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING DIALYSIS.
IT WAS REPORTED AND LEARNED THROUGH THE REVIEW OF THE LITERATURE EMERGENT TRANSCAROTID TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION IN DEGENERATIVE INSPIRIS RESILIA AORTIC VALVE, DECEMBER 03, 2025, BY TAIKI KITANO, TOMOHIKO TANIGUCHI, NATSUHIKO EHARA, TAKEICHIRO NAKANE, JIRO ESAKI, YUTAKA FURUKAWA. IT WAS LEARNED THAT A PATIENT WITH A 21MM 11500AJ AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY FIVE (5) YEARS DUE TO SEVERE STRUCTURAL VALVE DETERIORATION, SIGNIFICANT LEAFLET CALCIFICATION, AND SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH CLASS IV NYHA HEART FAILURE. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM SAPIEN3 ULTRA RESILIA VALVE SUCCESSFULLY. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED. THE DOCTOR BELIEVES THAT BEING ON DIALYSIS FOR END-STAGE KIDNEY DISEASE HAS LED TO LEAFLET DEGENERATION AND CALCIFICATION.
IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500AJ AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY FIVE (5) YEARS DUE TO AORTIC STENOSIS, STRUCTURAL VALVE DETERIORATION, AND LEAFLET CALCIFICATION. THE PATIENT EXPERIENCED DIFFICULTY UNDERGOING DIALYSIS AND PRESENTED WITH DYSPNEA. THE TAVR PROCEDURE WAS PERFORM WITH A 23MM SAPIEN3 ULTRA RESILIA VALVE SUCCESSFULLY. THE PATIENT IS IN THE HOSPITAL WITH STABLE CONDITION. PATIENT OUTCOME WAS REPORTED AS UNDER TREATMENT. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DOCTOR COMMENTED THAT HE BELIEVED THAT LEAFLET DEGENERATION DUE TO CALCIFICATION LED TO THE EVENT BECAUSE THE PATIENT WAS UNDERGOING DIALYSIS.
IT WAS REPORTED AND LEARNED THROUGH THE REVIEW OF THE LITERATURE EMERGENT TRANSCAROTID TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION IN DEGENERATIVE INSPIRIS RESILIA AORTIC VALVE, (B)(6) 2025, BY (B)(6). IT WAS LEARNED THAT A PATIENT WITH A 21MM 11500AJ AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY FIVE (5) YEARS DUE TO SEVERE STRUCTURAL VALVE DETERIORATION, SIGNIFICANT LEAFLET CALCIFICATION AND SEVERE AORTIC STENOSIS. THE PATIENT PRESENTED WITH CLASS IV NYHA HEART FAILURE. THE TAVR PROCEDURE WAS PERFORM WITH A 23MM SAPIEN3 ULTRA RESILIA VALVE SUCCESSFULLY. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED. THE DOCTOR BELIEVES THAT BEING ON DIALYSIS FOR END-STAGE KIDNEY DISEASE HAS LED TO LEAFLET DEGENERATION AND CALCIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434197 | EDWARDS INSPIRIS RESILIA AORTIC VALVE | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | EDWARDS LIFESCIENCES | 11500AJ21 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Unknown | Life Threatening| H| R |