BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPRO

    MDR report key: 1666696 · Received April 14, 2010

    Report

    Report Number
    1666696
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 14, 2010
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN AORTIC VALVE WAS PLACED INTO THE HEART DURING AN OPEN HEART PROCEDURE, IT APPEARED THAT THERE WAS A TEAR IN THE VALVE FABRIC SO THAT THE STRUTS WERE EXPOSED AND THE VALVE SEWING RING WAS DISRUPTED. HEALTH PROFESSIONAL'S IMPRESSION======================THIS APPEARED TO BE POSSIBLY BECAUSE OF THE TENSION ON THE VALVE WAS EXCESSIVE SO A SMALLER VALVE WAS SELECTED AND THE DEFECTIVE VALVE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPRO REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES LLC 3000TFX 27MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR