BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTMASTER JOSTENT

    MDR report key: 3062770 · Received April 11, 2013

    Report

    Report Number
    MW5029760
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATHETERIZATION, AFTER INITIAL DEPLOYMENT OF A VISION STENT, THERE WAS SEVERE CHEST PAIN WITH A CORONARY RUPTURE. WHILE THE VISION BALLOON WAS INFLATED TO BLOCK RUPTURE, A 4.0/12MM GRAFTMASTER COVERED STENT WAS PREPPED. THE VISION BALLOON WAS DEFLATED AND WITHDRAWN. THE GRAFTMASTER COVERED STENT WAS ADVANCED AND PLACED SO AS TO COVER THE PROXIMAL EDGE OF VISION STENT AND LOCATION OF RUPTURE. DESPITE MULTIPLE ATTEMPTS, THE BALLOON TO THE GRAFTMASTER COVERED STENT WOULD NOT INFLATE. HENCE THE STENT DID NOT DEPLOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155160 GRAFTMASTER JOSTENT COVERED STENT MAF ABBOTT VASCULAR GRAFTMASTER JOSTENT 740231

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other