BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1895342 · Received November 10, 2010

    Report

    Report Number
    2015691-2010-14340
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN. REQUESTS WERE MADE FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. THE DEVICE IS NOT AVAILABLE FOR RETURN AS RISK MANAGEMENT WILL NOT RELEASE THE DEVICE, PENDING PATIENT RELEASE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AORTIC MAGNA VALVE (2800 27MM) WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 65 MONTHS DUE TO SEVERE CALCIFICATION AND HARD AS A ROCK. THE DEVICE IS NOT AVAILABLE FOR RETURN AS RISK MANAGEMENT WILL NOT RELEASE THE DEVICE, PENDING PATIENT RELEASE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 4L1760

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention