EDWARDS INSPIRIS RESILIA AORTIC VALVE
Report
- Report Number
- 2015691-2024-04905
- Event Type
- Injury
- Date Received
- June 26, 2024
- Report Date
- July 31, 2024
- 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
UPDATED SECTIONS: G3, G6, H6 INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE PERFORMED, AS THE DEVICE LOT/SERIAL NUMBER WAS NOT PROVIDED. TISSUE DEGENERATION-RELATED STRUCTURAL DETERIORATION, EITHER CALCIFIC OR NON-CALCIFIC, ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVE. OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NONCALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CAUSED OR CONTRIBUTED TO THE EVENT.
UPDATED SECTIONS: B5, B6, G3, G6, H6 HEALTH EFFECT - CLINICAL CODE, AND TYPE OF INVESTIGATION. ARTICLE CITATION: HIROTA, M, DOMOTO, S, INAGAKI, Y. ET AL. TRANSCATHETER SELF-EXPANDABLE AORTIC VALVE IMPLANTATION IN THE EXPANDABLE SURGICAL AORTIC VALVE. J AM COLL CARDIOL INTV. 024 JUN,17 (11) 1397-1399. HTTPS://DOI.ORG/10.1016/J.JCIN.2024.04.009.
THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. 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.
EDWARDS REVIEWED THE LITERATURE ARTICLE, TRANSCATHETER SELF-EXPANDABLE AORTIC VALVE IMPLANTATION IN THE EXPANDABLE SURGICAL AORTIC VALVE, IN JACC: CARDIOVASCULAR INTERVENTIONS. VOL 17, NO. 11, 2024. EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH A 19MM 11500AJ AORTIC VALVE IMPLANTED APPROXIMATELY SIX (6) YEARS UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS SECONDARY TO SEVERE STRUCTURAL VALVE DETERIORATION. SYMPTOMS OF HEART FAILURE AND DYSPNEA WAS SEEN. THE ELECTROCARDIOGRAM SHOWED A COMPLETELY RIGHT BUNDLE BLOCK. THE DEVICE WAS REPLACED WITH A NON-EDWARDS VALVE WITHOUT ANY ADVERSE EVENT REPORTED. PATIENT WAS DISCHARGED FROM THE HOSPITAL.
EDWARDS RECEIVED INFORMATION THAT A PATIENT WITH A 19MM 11500AJ AORTIC VALVE IMPLANTED APPROXIMATELY SIX (6) YEARS UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS SECONDARY TO STRUCTURAL VALVE DETERIORATION. SYMPTOMS OF HEART FAILURE AND DYSPNEA WAS SEEN. THE DEVICE WAS REPLACED WITH A NON-EDWARDS VALVE WITHOUT ANY ADVERSE EVENT REPORTED. PATIENT WAS DISCHARGED FROM THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430451 | EDWARDS INSPIRIS RESILIA AORTIC VALVE | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | EDWARDS LIFESCIENCES | 11500AJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Required Intervention| L| H |