BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIKTOR PRIME DELIVERY SYSTEM

    MDR report key: 166538 · Received May 6, 1998

    Report

    Report Number
    2083093-1998-00078
    Event Type
    Injury
    Date Received
    May 6, 1998
    Date of Event
    August 1, 1997
    Report Date
    April 21, 1998
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS PROVIDED ON TWO WIKTOR STENTS ON A DEVICE TRACKING REGISTRATION FORM: REMOVED, NOT DEPLOYED, RETRIEVED WITH A SNARE. REF MEDWATCH REPORT 2083098-1998-00077 FOR THE OTHER DEVICE. ALTHOUGH NO PT INJURY OR INTERVENTION WAS REPORTED THIS REPORT IS BEING FILED SINCE THIS TYPE OF EVENT COULD CAUSE AN ADVERSE EVENT IF IT WERE TO RECUR. THE INSTRUCTIONS FOR USE INDICATES, STENT RETRIEVALS (USE OF ADDITIONAL WIRES, SNARES AND/OR FORCEPS) MAY RESULT IN ADDITIONAL TRAUMA TO THE VASCULAR ACCESS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIKTOR PRIME DELIVERY SYSTEM Implant CORONARY STENT DELIVERY SYSTEM MAF MEDTRONIC INTERVENTIONAL VASCULAR 6565 J97224875

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention