BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PERICARDIAL MITRAL BIOPROSTHESIS

    MDR report key: 11902756 · Received May 28, 2021

    Report

    Report Number
    2015691-2021-03220
    Event Type
    Injury
    Date Received
    May 28, 2021
    Report Date
    July 16, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS, MODEL# 7300TFX, PMA# P860057/S068 THE DEVICE WAS EXPLANTED > 0 DAYS FOR UNKNOWN REASONS. ALTHOUGH THERE ARE MULTIPLE ROOT CAUSES, VALVES ARE TYPICALLY EXPLANTED BECAUSE THEY ARE NOT FUNCTIONING OPTIMALLY. MINIMAL INFORMATION REGARDING THIS PROCEDURE WAS RECEIVED AND ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN UNSUCCESSFUL. THE ROOT CAUSE OF THE EVENT REMAINS INDETERMINABLE. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) WAS NOT ABLE TO BE REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. 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 REVIEWED THE PRESENTATION FROM THE ANNUAL MEETING (2021) OF AMERICAN ASSOCIATION FOR THORACIC SURGERY (AATS). "MITRAL VALVE REPLACEMENT USING A PERICARDIAL VALVE WITH RESILIA TISSUE" FROM THE EDWARDS COMMENCE TRIAL - MITRAL ARM. THE FOLLOWING COMPLAINT WAS IDENTIFIED: A MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797124 EDWARDS PERICARDIAL MITRAL BIOPROSTHESIS TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 11000M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R