BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS

    MDR report key: 3900462 · Received June 27, 2014

    Report

    Report Number
    2015691-2014-01484
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P010041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PENDING RETURN TO EDWARDS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, THE NON-CORONARY LEAFLET HAD A CUT OF APPROXIMATELY 6MM IN LENGTH IN THE BELLY. THE EDGE NEAR THE RIGHT-CORONARY AND NON-CORONARY (RC-NC) ATTACHMENT SITE APPEARED TO HAVE A STRAIGHT AND EVEN EDGE, WHICH ARE CHARACTERISTIC OF CUTS. THIS DAMAGE IS LIKELY DUE TO IMPLANT OR EXPLANT. NO VISIBLE INCONSISTENCIES WERE OBSERVED ON THE REMAINING LEAFLETS NOR WERE ANY DETECTED ON THE X-RAY AS THE WIREFORM REMAINED INTACT. METHOD: X-RAY. RESULT: CLINICAL OBSERVATION CONFIRMED. CONCLUSION: CONSISTENT WITH DAMAGE OCCURRING DURING THE IMPLANT OR EXPLANT PROCEDURE. LIKELY ASSOCIATED WITH SURGICAL INSTRUMENTATION. THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS AND THE CLINICAL OBSERVATION COULD BE CONFIRMED. 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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS 21 MM BIOPROSTHETIC HEART VALVE WAS EXPLANTED AT IMPLANT DUE TO A REPORTED "CRACK" IN ONE LEAFLET, DESCRIBED TO BE 5-6MM IN LENGTH, WHICH WAS REPORTEDLY NOT VISIBLE TO THE NAKED EYE. THIS WAS REPLACED WITH A MECHANICAL HEART VALVE WHICH MAY HAVE CONTRIBUTED TO A "PROLONGED CARDIAC ARREST TIME." IT WAS FURTHER REPORTED THE PATIENT STAYED IN THE INTENSIVE CARE UNIT FOR SEVEN (7) DAYS, POST-OPERATIVELY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377690 CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2650

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R