BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 19469489 · Received June 5, 2024

    Report

    Report Number
    2015691-2024-04339
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 16, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103194999
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, D4 (EXPIRATION DATE), G3, G6, H2, H6 (COMPONENT CODE, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED, AS NO INFORMATION REGARDING A DEVICE FAILURE MODE WAS PROVIDED. FURTHERMORE, 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 DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR (DOC-0101337). THE COMPLAINT INVESTIGATION WAS CONDUCTED, USING EVALUATION SUMMARY DOC-0212705 AND TRIAGE LEVEL 1, IN ACCORDANCE WITH TCA DOC-0226303 REV. D. 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. PER THE INSTRUCTIONS FOR USE (IFU), REOPERATION/EXPLANT ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC CARDIAC VALVES AND ANNULOPLASTY RINGS. 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT (PRA) NOR CORRECTIVE OR PREVENTIVE ACTIONS (CAPA/SCAR) ARE REQUIRED AT THIS TIME, PER DOC-0101337 AND DOC-0076862. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. ALL PERTINENT INFORMATION AVAILABLE TO EDWARDS LIFESCIENCES HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11500A INSPIRIS VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814398 INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A25 00690103194999

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| L| R