BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEWROOT0030#CARDIOROOT

    MDR report key: 6430339 · Received March 23, 2017

    Report

    Report Number
    2242352-2017-00304
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 23, 2017
    Manufacturer
    MAQUET SAS
    Product Code
    MAL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOVASCULAR FILES AS THE IMPORTER FOR THIS DEVICE. INTERVASCULAR SAS IS RESPONSIBLE FOR MANUFACTURER REPORTING.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN CARDIOROOT PROCEDURE, GRAFT FRAYED DURING THE OPERATION. PA WAS CREATING A BIOBENTAL WITH THIS AND A MAGNA HEART VALVE. THE NECESSITATED STOPPING TWICE TO DEAL WITH FRAYING OF THE GRAFT AND AT ONE POINT I THOUGHT WE WERE GOING TO HAVE TO OPEN A SECOND MAGNA VALVE AND START OVER AS THE FRAYING WAS GETTING BAD. NOT ONLY WOULD THIS HAVE BEEN A COST ISSUE, THIS PATIENT IS QUITE ILL WITH EJECTION FRACTION 25% AND THE ADDED CARDIAC ISCHEMIC TIME AND CARDIOPULMONARY BYPASS TIME RELATED TO THIS GRAFT ISSUE WAS SEVERELY SUBOPTIMAL. IN MY ESTIMATION IT EXTENDED HIS CARDIAC ISCHEMIC PERIOD OF HIS ALREADY COMPROMISED HEART BY 10-15 MINUTES AND ALSO HIS CPB TIME IF THE GRAFT HAD FRAYED ANY MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210307 HEWROOT0030#CARDIOROOT GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE MAL MAQUET SAS 16G21

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention