BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIKTOR CORONARY STENT DELIVERY SYSTEM

    MDR report key: 122626 · Received September 26, 1997

    Report

    Report Number
    2083093-1997-00046
    Event Type
    Injury
    Date Received
    September 26, 1997
    Date of Event
    August 28, 1997
    Report Date
    September 25, 1997
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION REVEALED A BOND FAILURE. THE CAUSE WAS DETERMINED TO BE DUE TO LACK OF CLARIFICATION OF THE TESTING AND INSPECTION PROCESS. MFG INSTRUCTIONS DOCUMENTATION HAVE BEEN CLARIFIED AND ALL OPERATORS TRAINED TO THE NEW INSPECTION CRITERIA.

    Description of Event or Problem · 1

    A WIKTOR STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING AN ATTEMPT TO IMPLANT A SECOND WIKTOR STENT PROXIMAL TO THE FIRST STENT, THE PHYSICIAN OBSERVED THE STENT COULD NOT BE DEPLOYED. A POWER INJECTOR DEVICE WAS USED IN AN ATTEMPT TO DEPLOY THE STENT WHICH RESULTED IN A PROXIMAL SHAFT TEAR. THE STENT WAS RETRIEVED WITH A SNARE. A THIRD STENT WAS SUCCESSFULLY DEPLOYED PROXIMAL TO THE FIRST STENT. NO 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. 6575 J97224856

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention