BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT® MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 3831119 · Received May 23, 2014

    Report

    Report Number
    2015691-2014-01234
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 8, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT THE RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A (B)(4) BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION REVEALED AORTIC BIOPROSTHETIC VALVE EXHIBITED DETERIORATION, PRESENTING WITH STENOSIS AND REGURGITATION. THE VALVE WAS EXPLANTED AND REPLACED WITH A PERICARDIAL VALVE. PATIENT TOLERATED PROCEDURE WELL AND REPORTED TO BE IN STABLE CONDITION POST-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308933 CARPENTIER-EDWARDS PERIMOUNT® MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 300025MM

    Patients

    Seq Age Sex Outcome Treatment
    1 56 Required Intervention