BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 1661145 · Received April 18, 2010

    Report

    Report Number
    2015691-2010-13135
    Event Type
    Death
    Date Received
    April 18, 2010
    Date of Event
    November 14, 2009
    Report Date
    March 18, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), A COPY OF THE OPERATIVE REPORT WAS RECEIVED. UNFORTUNATELY, NO FURTHER DETAILS REGARDING THE EVENT WAS LEARNED. 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 PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.2 MONTHS, DUE TO UNKNOWN REASONS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED FOR THE SURGERY OCCURRING APPROXIMATELY A WEEK BEFORE THE PATIENT'S DEATH. UNFORTUNATELY, NO INFORMATION REGARDING THE REPORTED EVENT WAS LEARNED.

    Description of Event or Problem · 1

    THE DEVICE INVOLVED IN THIS REPORT EXHIBITED A LOW BATTERY VOLTAGE (CONSIDERING THE IMPLANTATION DURATION) AT ROUTINE FOLLOW-UP. PRELIMINARY ANALYSIS OF AVAILABLE DATA REVEALED A FAST BATTERY DEPLETION CONSIDERING DEVICE SETTINGS AND DELIVERED THERAPY. THEREFORE, DEVICE REPLACEMENT WAS RECOMMENDED ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 09G174

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death