SEE H10
Report
- Report Number
- 2015691-2022-06458
- Event Type
- Injury
- Date Received
- June 30, 2022
- Date of Event
- June 8, 2022
- Report Date
- August 3, 2022
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #8300AB; BRAND NAME: EDWARDS INTUITY ELITE VALVE SYSTEM; PMA #P150036. 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.
(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION...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, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. 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. THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE DUE TO PATIENT RELATED FACTORS. THE REGURGITATION IN THIS CASE WAS IMPACTED BY THE PROGRESSION OF THE PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT STRUCTURAL VALVE DETERIORATION AND/OR NONSTRUCTURAL DYSFUNCTION, INCLUDING HLD AND CAD. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. 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.
IT WAS REPORTED THAT THIS PATIENT WITH A 25MM 8300ACA AORTIC VALVE, IMPLANTED FOR NINE (9) YEARS AND ONE (1) MONTH, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND REGURGITATION. THE TAVR WAS PERFORMED WITH A 26MM S3U SUCCESSFULLY. THERE IS NO INDICATION OR EVIDENCE OF PREMATURE FAILURE OF THE SURGICAL VALVE.
IT WAS REPORTED THAT THIS PATIENT WITH A 25MM 8300ACA AORTIC VALVE, IMPLANTED FOR NINE (9) YEARS AND ONE (1) MONTH, UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO MILD STENOSIS AND SEVERE REGURGITATION SECONDARY TO RESTRICTED LEAFLET MOTION AND SEVERE PROLAPSED/FLAILED LEAFLET. THE PATIENT PRESENTED WITH SOB ON EXERTION. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO THE ICU IN STABLE CONDITION. THERE IS NO INDICATION OR EVIDENCE OF PREMATURE FAILURE OF THE SURGICAL VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1480322 | SEE H10 | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | EDWARDS LIFESCIENCES | 8300ACA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Required Intervention| L| H |