BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1802502 · Received August 17, 2010

    Report

    Report Number
    2015691-2010-13889
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 4, 2010
    Report Date
    July 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ONLY A COPY OF THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 72.77 MONTHS. THROUGH THE OPERATIVE REPORT, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO SEVERE AORTIC STENOSIS. PANNUS GROWTH ON ALL THREE LEAFLETS WAS ALSO OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 4D0601

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention