BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

    MDR report key: 2120893 · Received June 12, 2011

    Report

    Report Number
    2015691-2011-15701
    Event Type
    Injury
    Date Received
    June 12, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 11, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P000007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RECEIVED ONE 2500P PRIMA PLUS VALVE. UPON EXAMINATION, THE AORTIC WALL TISSUE APPEARS TO HAVE BEEN CUT PASSED THE TRIMMING GUIDE. SOME GREEN SUTURES OF THE TRIMMING GUIDE LINE ARE MISSING, MOST LIKELY DUE TO THE TISSUE CUT OUT. NO OTHER INCONSISTENCIES WERE DETECTED IN THE VALVE AS THE LEAFLETS ARE INTACT AND FLEXIBLE. NO INCONSISTENCIES WERE DETECTED IN THE X-RAY AS WELL. EDWARDS PRINCIPAL ENGINEER OBSERVED THE VALVE DURING THE EVALUATION REVIEW AND HAS APPROVED THESE COMMENTS. METHOD: X-RAY.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. COPY OF ECHOCARDIOGRAPHY ON CD REQUESTED, BUT IS NOT AVAILABLE. OPERATIVE REPORT HAS BEEN PROVIDED, BUT NOT TRANSLATED.

    Description of Event or Problem · 1

    ON (B096) 2011, THE SURGEON PROVIDED THE FOLLOWING INFORMATION: THE RUPTURE OCCURRED AT THE ACORONARY IMPLANTATION SIDE, ALONG THE SUTURE LINE, WHERE THE DACRON OF THE ROOT PROTHESIS IS FIXED TO THE NATIVE AORTIC WALL OF THE PROSTHESIS. THE RUPTURE HAPPENED AFTER WE WENT OFF THE EXTRACORPORAL CIRCULATION EASILY, SHORTLY BEFORE I STARTED TO CLOSE THE CHEST. SUDDENLY, SOME BLEEDING CAME FROM THE ROOT AND WE CANULATED AND PUT THE PATIENT ON BYPASS AGAIN. AFTER CROSSCLAMPING, WE FOUND THE ROOT RUPTURED AND REPLACED IT.

    Description of Event or Problem · 1

    REPORTEDLY, THE VALVE WAS EXPLANTED SOON AFTER IMPLANTATION DUE TO A RUPTURE. PER THE CER: PROTHESIS RUPTURE AFTER IMPLANTATION INTRAOPERATIVELY. PROTHESIS EXCHANGE. FROM THE TRANSLATED OPERATIVE REPORT SUMMARY PROVIDED: IMPLANT OF THE 2500AP27 WAS UNEVENTFUL. AFTER SUFFICIENT REPERFUSION AND WARMING UP, SLOWLY WEANING OFF FROM ECC. NOW A BLEEDING OCCURRED FROM THE BIOPROSTHESIS. IT WAS DECIDED TO REPLACE THE PROSTHESIS. EXPLANT OF THE EDWARDS VALVE AND IMPLANT OF THE MEDTRONIC VALVE UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2500P R-11C0982

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R