BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1918935 · Received December 9, 2010

    Report

    Report Number
    2015691-2010-14503
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    August 23, 2010
    Report Date
    November 11, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. (B)(4) = PARTIAL OBSTRUCTION OF THE LVOT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT AND/OR DEVICE STATUS IS REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. ON 11/16/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), ADDITIONAL INFORMATION WAS RECEIVED. IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO PARTIAL OBSTRUCTION OF THE LVOT. ACCORDING TO THE OPERATIVE REPORT, AFTER THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS, THE PATIENT WAS NOTED TO HAVE SOME HEMODYNAMIC COMPROMISE. SHE REQUIRED REPEAT BOLUSES OF VOLUME AND ESCALATING EPINEPHRINE BUT HER HYPOTENSION BECAME MORE AND MORE RECALCITRANT TO CORRECTION. THE TEE REVEALED GOOD MV FXN BUT SUGGESTED ELEVATED VELOCITIES ACROSS THE LVOT. HER PICTURE WAS CONSISTENT WITH A LVOT OBSTRUCTIVE PATTERN THAT SEEMED TO NOT IMPROVE FOR LONG WITH VOLUME AND POSSIBLY WORSENED WITH POSITIVE INOTROPHY. THE PATIENT WAS PLACED BACK ON BYPASS, AND THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER VALVE OF THE SAME MODEL AND SIZE. PER THE HEALTH-CARE PROVIDER, THIS WAS A PROCEDURE RELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-10D0991

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention