BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 4192640 · Received October 21, 2014

    Report

    Report Number
    4192640
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES CORP
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WHO HAD UNDERGONE AORTIC VALVE REPLACEMENT IN 2010 FOR SEVERE AORTIC STENOSIS AND INSUFFICIENCY. HE DID WELL FOR A NUMBER OF YEARS AND HAD IMPROVED LEFT VENTRICULAR FUNCTION. ECHOCARDIOGRAM IN 2013 AT THAT TIME SHOWED GOOD LEFT VENTRICULAR FUNCTION WITH A WELL-FUNCTIONING PROSTHETIC VALVE. HOWEVER, IN THE LAST 3-6 MONTHS, HE HAS HAD MORE PROGRESSING DYSPNEA AND SOME FATIGUE BUT ALSO HAS NOW HAD 2 SYNCOPAL EPISODES, MOST RECENT ONE EARLIER THIS MORNING. SCHEDULED FOR AN ELECTIVE RE-DO STERNOTOMY, RE-DO AORTIC VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669617 PERIMOUNT MAGNA AORTIC BIOPROSTHESIS AORTIC VALVE-BIOPROSTHESIS DYE EDWARDS LIFESCIENCES CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention