BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIKTOR CORONARY STENT DELIVERY SYSTEM

    MDR report key: 112129 · Received August 8, 1997

    Report

    Report Number
    2083093-1997-00033
    Event Type
    Injury
    Date Received
    August 8, 1997
    Date of Event
    July 10, 1997
    Report Date
    August 5, 1997
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER SUCCESSFULLY DEPLOYING A WIKTOR STENT ANOTHER MFR'S PTCA BALLOON WAS USED FOR POST DILATATION. DIFFICULTY DURING REMOVAL OF THE BALLOON CAUSED THE PROXIMAL PORTION OF THE STENT TO BECOME STRETCHED. THE POSITION OF THE GUIDING CATHETER WAS LOST WHILE DEPLOYING A SECOND STENT WHICH DISLODGED FROM THE BALLOON AS THE CATHETER WAS REMOVED. THE PT ARRESTED AND REQUIRED DEFIBRILLATION. AFTER THE PT WAS STABILIZED THE SECOND STENT WAS FOUND EMBEDDED IN THE FEMORAL ARTERY. THERE WERE NO ATTEMPTS TO RETRIEVE THE STENT AND THE PT WENT TO ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIKTOR CORONARY STENT DELIVERY SYSTEM Implant CORONARY STENT DELIVERY SYSTEM MAF MEDTRONIC INTERVENTIONAL VASCULAR, INC. 6570 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention SCIMED BANDIT BALLOON CATHETER