BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4201502 · Received October 27, 2014

    Report

    Report Number
    2015691-2014-02518
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, ALL THREE LEAFLETS WERE SLIGHTLY DEHYDRATED. LEAFLETS APPEARED SLIGHTLY STIFF AND SLIGHTLY TRANSLUCENT-LIKE IN APPEARANCE. THE XRAY DEMONSTRATED COMMISSURE 1 WIREFORM DISTORTED. THESE DAMAGES ARE MOST LIKELY DUE TO IMPLANT OR EXPLANT. METHOD: X-RAY, ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THERE ARE SEVERAL REASONS WHY A VALVE IS EXPLANTED AT IMPLANT. THIS IS TYPICALLY THE RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IN THIS CASE, THE CUSTOMER REPORT AND ECHO REFERENCE SURGEON IMPLANTING A SMALLER VALVE. AFTER EVALUATION OF THE DEVICE, THE GROSS PHYSICAL EVALUATION DID NOT PROVIDE ANY ADDITIONAL INFORMATION TO CONFIRM THE CLINICAL OBSERVATIONS MADE BY THE HEALTH CARE PROVIDER. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS HAS LEARNED OF A 27MM AORTIC PERICARDIAL VALVE EXPLANTED AT IMPLANT DUE TO MODERATE AI. SURGEON MEASURED WITH A 29MM SIZER AND DECIDED TO USE A 27MM VALVE. WHEN HE CAME OFF PUMP, PATIENT HAD MODERATE AI ON ECHO WHICH WAS CONSIDERED UNACCEPTABLE. HE WENT BACK ON PUMP, EXPLANTED THE 27MM AND IMPLANTED A 25MM WHICH THEN HAD A NORMAL ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684352 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R