BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19667677 · Received July 3, 2024

    Report

    Report Number
    3012608866-2024-00013
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 24, 2022
    Report Date
    July 3, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    UDI-DI
    00850003494036
    PMA / PMN Number
    P180034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H3: THE TES DEVICE WAS DISCARDED BY THE FACILITY, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BLOCK H6: IFU INTENDED USE: -TACK IS INDICATED FOR USE IN THE SFA AND PROXIMAL POP ARTERIES, AND NOT INDICATED FOR USE IN THE COMMON FEMORAL ARTERY. IFU WARNING/PRECAUTIONS: -AVOID MOVING TACK CATHETER THROUGH ALREADY DEPLOYED TACK IMPLANTS WHEN POSSIBLE. -FAILURE TO PERFORM A POST TACK IMPLANT BALLOON INFLATION MAY RESULT IN INADEQUATE TISSUE APPOSITION AND/OR INABILITY TO SEAT THE ANCHORS. -TACK IMPLANT MAY CAUSE DISTAL EMBOLIZATION OR MIGRATION FROM THE SITE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE IN THE DISTAL COMMON FEMORAL ARTERY. DURING USE, A TACK WAS DEPLOYED IN THE ARTERY, REMOVED THE DEVICE, AND PERFORMED ANGIO. THE PHYSICIAN WANTED TO PLACE A SECOND TACK PROXIMAL TO THE ORIGINAL TACK LOCATION; HOWEVER, DID NOT POST DILATE THE FIRST TACK AND PUSHED THE TACK FURTHER DOWN THE ARTERY. THE SYSTEM WAS REMOVED WITHOUT DEPLOYING THE SECOND TACK, AND A BALLOON WAS USED TO POST DILATE THE TACK. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TACK MIGRATED. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785646 TACK ENDOVASCULAR SYSTEM (6F, 4.0-8.0MM) SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. 206135061 249493 00850003494036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 0.035" GUIDEWIRE, MFG UNK.| COOK: 6F INTRODUCER SHEATH.