BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

    MDR report key: 2982749 · Received February 28, 2013

    Report

    Report Number
    2015691-2013-19411
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P000007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE DEVICE WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED AT THE HOSPITAL. NO PATIENT HISTORY OR OPERATIVE REPORT ARE AVAILABLE AND NO ECHO WILL BE PROVIDED. CONCLUSION: THE SURGEON DESCRIBES HOLES AND TEARS IN THE LEAFLETS WITH NO EVIDENCE OF CALCIFICATION. SEQUENTIAL DESIGN IMPROVEMENTS HAVE INCREASED THE DURABILITY OF BIOPROSTHETIC VALVES. HOWEVER, FAILURES EARLIER THAN ANTICIPATED DUE OCCUR IN A SMALL NUMBER OF PATIENTS. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. STRUCTURAL VALVE DETERIORATION (SVD) MAY OCCUR AS A RESULT OF NON-CALCIFIC DEGENERATION. NON-CALCIFIC DEGENERATION IS CHARACTERIZED PHYSIOLOGICALLY BY MODERATE TO SEVERE REGURGITATION AND GROSSLY BY PARTIAL TO COMPLETE LOSS OF LEAFLET ARCHITECTURE. IN VITRO AND IN-VIVO TESTING HAVE DEMONSTRATED CONSISTENT PATTERNS OF STRUCTURAL DAMAGE FROM NON-CALCIFIC DEGENERATION, WITH COLLAGEN LOSS WITHIN THE BELLIES OF THE LEAFLETS. THEREFORE, THIS MODE OF FAILURE INCLUDED CUSP TEARS AND PERFORATIONS WITHIN THE BODY OF THE CUSPS THAT WERE UNRELATED TO LEAFLET SEPARATION FROM THE STENT AND DISTINCT FROM TEARS ASSOCIATED WITH CALCIFICATION. HOWEVER, AS THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, WE ARE UNABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    Description of Event or Problem · 1

    REPORTEDLY, A 27MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS AND 10 MONTHS (94 MONTHS) DUE TO AORTIC REGURGITATION (AR). THE CUSTOMER REPORTED A PRIMA PLUS VALVE, MODEL 2500P27MM, WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT (AVR) TO CORRECT AR ON (B)(6) 2005. ON (B)(6) 2013, THE VALVE WAS EXPLANTED AND THE ASCENDING AORTA WAS RESECTED FOR BENTALL PROCEDURE AND REPLACED WITH A 23MM DEVICE. AT EXPLANT, A HOLE ON LEFT CORONARY CUSP WAS OBSERVED. THE OTHER TWO CUSPS WERE ALSO WEAKENED. MINIMAL CALCIFICATION WAS DETECTED ON ALL CUSPS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED AT THE HOSPITAL. ECHO REPORT WILL NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86602 EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2500P 04E083

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R