BEUDAMED
    FDA Adverse Event Death Summary report: N

    WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM

    MDR report key: 134930 · Received November 6, 1997

    Report

    Report Number
    2083093-1997-00064
    Event Type
    Death
    Date Received
    November 6, 1997
    Date of Event
    November 4, 1997
    Report Date
    November 6, 1997
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A COMPLEX ANGIOPLASTY OF THE LEFT CIRCUMFLEX AND MARGINAL BIFURCATION LESION THREE WIKTOR STENTS WERE PLACED. THE FIRST WIKTOR STENT WAS PLACED IN THE MARGINAL ARTERY. DURING BALLOON PREP THE PT FIBRILLATED AND COMPRESSIONS WERE STARTED. THE DELIVERY SYSTEM WAS REMOVED AT THIS TIME LEAVING AN UNDEPLOYED STENT. TWO MORE WIKTOR STENTS WERE DEPLOYED IN THE CIRCUMFLEX ARTERY IN AN ATTEMPT TO KEEP THE VESSEL OPEN. HOWEVER A SEVERE LEFT MAIN DISSECTION WAS NOTED WITH VESSEL CLOSURE AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM Implant CORONARY STENT DELIVERY SYSTEM MAF MEDTRONIC INTERVENTIONAL VASCULAR, INC. 6565 J97225092

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death