BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3013860 · Received March 20, 2013

    Report

    Report Number
    2015691-2013-19609
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 19, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE REPORTED "SCRATCH NOTICED ON ONE OF THE LEAFLETS" COULD NOT CONFIRMED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN THE SUBJECT DEVICE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT THE SAMPLE IS OBTAINED OR IF ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO "SCRATCH NOTICED ON ONE OF THE LEAFLETS" PRIOR TO THE PATIENT COMING OFF CARDIOPULMONARY BYPASS. THE HEALTHCARE PROVIDER FURTHER STATED, "THE SCRATCH WAS NOTED DURING THE FINAL INSPECTION OF THE VALVE AFTER IMPLANT. I NOTICED IT WHEN RINSING THE ROOT BEFORE CLOSURE OF AORTOTOMY. I AM NOT SURE WHEN AND HOW IT WAS DEVELOPED. THERE WERE NO OBVIOUS MISHAPS DURING THE PROCEDURE. I DECIDED TO EXPLANT AND REPLACE IT WITH A NEW ONE." THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE, SAME MODEL AND SIZE. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115674 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 3518914

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention