BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIKTOR PRIME STENT

    MDR report key: 112088 · Received July 29, 1997

    Report

    Report Number
    2083093-1997-00032
    Event Type
    Injury
    Date Received
    July 29, 1997
    Date of Event
    July 10, 1997
    Report Date
    July 25, 1997
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER SUCCESSFULLY DEPLOYING THE STENT IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY THE PT EXPERIENCED CHEST PAINS. THE PHYSICIAN DETERMINED AN ACUTE CLOSURE WITH THROMBOSIS HAD OCCURRED AND ELECTED TO SEND THE PT TO BYPASS SURGERY. NO PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIKTOR PRIME STENT Implant CORONARY STENT MAF MEDTRONIC INTERVENTIONAL VASCULAR, INC. 6570 J96-200452

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention