BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIKTOR CORONARY STENT DELIVERY SYSTEM

    MDR report key: 117862 · Received September 4, 1997

    Report

    Report Number
    2083093-1997-00044
    Event Type
    Injury
    Date Received
    September 4, 1997
    Date of Event
    July 22, 1997
    Report Date
    August 18, 1997
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RPT IS BEING SUBMITTED TO CORRECT THE MODEL NUMBER RPT'D IN THE ORIGINAL RPT OF 8/18/97. MODEL 65UNK WILL BE USED AS A DEFAULT MODEL NUMBER WHEN AN ADVERSE EVENT IS DETERMINED TO BE REPORTABLE AND THE MODEL NUMBER IS NOT PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    DURING IMPLANT OF A WIKTOR STENT A DISSECTION WAS OBSERVED PROXIMAL TO THE TARGET SITE. ANOTHER WIKTOR STENT WAS IMPLANTED TO ADDRESS THE DISSECTION. VESSEL DISSECTION IS A KNOWN POTENTIAL ADVERSE EFFECT OF VESSEL DILATATION. NO PRODUCT PERFORMANCE ISSUES OR PT COMPLICATIONS WERE REPORTED.

    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. 65UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention