BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801207 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01081
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    December 15, 2009
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS PATIENT EXPERIENCES REGURGITATION. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THIS BIOPROSTHETIC AORTIC VALVE EXHIBITED MODERATE AORTIC REGURGITATION AT SEVEN (7) MONTHS AFTER IMPLANT. THE REGURGITATION REMAINED MODERATE AT APPROXIMATELY THREE (3) YEARS AFTER IMPLANT. REGURGITATION/INSUFFICIENCY OF AORTIC AND MITRAL VALVES THAT IS DETECTED BY ECHOCARDIOGRAPHY WITH NO INDICATION FOR INTERVENTION SUGGESTS THE DEVICE CONTINUES TO PERFORM ITS ESSENTIAL FUNCTION. NO FURTHER ACTIONS ARE BEING TAKEN IN THIS CASE.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE HAS EXHIBITED SEVERE AORTIC REGURGITATION AT SEVEN (7) MONTHS AFTER IMPLANT. DEVICES REMAINS IMPLANTED. THERE ARE NO ADVERSE PATIENT EFFECTS REPORTED AT THIS TIME. BOVINE VALVE NO 26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278572 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other