BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACK ENDOVASCULAR SYSTEM (6F, 4.0 - 8.0MM)

    MDR report key: 12051440 · Received June 23, 2021

    Report

    Report Number
    3012608866-2021-00003
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 9, 2021
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    UDI-DI
    00850003494036
    PMA / PMN Number
    P180034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO INTACT VASCULAR FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IF ANY ADDITIONAL INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE, INTACT VASCULAR WILL SUBMIT A 3500A SUPPLEMENTAL REPORT ACCORDINGLY.

    Description of Event or Problem · 1

    UPON POST DILATION OF THE TACKS, THE BALLOON PASSED THE FIRST TACK WITHOUT ISSUE BUT CAME INTO CONTACT WITH THE SECOND TACK. THE BALLOON BECAME CAUGHT ON THE SECOND TACK. THE BALLOON PUSHED THE TACK SIDEWAYS IN THE VESSEL AND THEN DOWN THE SUPERFICIAL FEMORAL ARTERY (SFA). EVENTUALLY, THE OPERATOR WAS ABLE TO USE A STENT TO OVERLAY THE DISPLACED TACK, SECURING IT AGAINST THE VESSEL WALL. A SELF-EXPANDING STENT WAS PLACED IN THE PROXIMAL SFA TO COVER THE DISSECTIONS. AT THE CONCLUSION OF THE PROCEDURE, THERE WAS COMPLETE FLOW THROUGH THE SFA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951581 TACK ENDOVASCULAR SYSTEM (6F, 4.0 - 8.0MM) TACK ENDOVASCULAR SYSTEM (6F, 2.0 - 8.0MM) QCT INTACT VASCULAR, INC. 6F 243668 00850003494036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention