BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 4191041 · Received October 21, 2014

    Report

    Report Number
    2015691-2014-02480
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THROUGH FOLLOW-UP WITH THE HEALTH CARE PROVIDER, IT WAS LEARNED THIS DEVICE HAD SEVERE CALCIFICATION OF TWO OF THE LEAFLETS, WHICH DID NOT PERMIT THEM TO OPEN ADEQUATELY, RESULTING IN STENOSIS. ATTEMPTS ARE BEING MADE TO RETURN THE DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THROUGH ITS IMPLANT PATIENT REGISTRY THAT A 29MM BIOPROSTHETIC MITRAL VALVE, IMPLANTED APPROXIMATELY ELEVEN (11) YEARS AND FOUR (4) MONTHS, WAS EXPLANTED AND REPLACED WITH A 6925-ESR-LP 29MM VALVE. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, IT WAS LEARNED THIS DEVICE WAS EXPLANTED DUE TO CALCIFICATION OF THE LEAFLETS AND MITRAL STENOSIS. THE RESPONSE ALSO INDICATED THERE WAS PANNUS/HOST TISSUE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669934 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R