BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACK ENDOVASCULAR SYSTEM

    MDR report key: 16678142 · Received April 4, 2023

    Report

    Report Number
    3012608866-2023-00001
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 4, 2023
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    UDI-DI
    00863328000127
    PMA / PMN Number
    P180034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT''S DOB OR AGE AT TIME OF EVENT, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. THE TACK DEVICE WAS DISCARDED BY THE FACILITY, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BASED ON THE COMPLAINT DETAILS, THE USER FAILED TO FOLLOW THE IFU. THE IFU WARNS THAT FAILURE TO PERFORM A POST TACK IMPLANT BALLOON INFLATION MAY RESULT IN INADEQUATE TISSUE APPOSITION AND/OR INABILITY TO SEAT THE ANCHORS. 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 TO TREAT A SLIGHTLY CALCIFIED SOFT TISSUE IN THE TIBIOPERONEAL TRUNK (TP). THE FIRST TACK WAS DEPLOYED IN THE DISTAL TP AT THE ORIGIN OF THE OCCLUDED POSTERIOR TIBIAL ARTERY. THE SECOND TACK WAS DEPLOYED IN THE MIDDLE TP, AND THE THIRD TACK WENT IN TO THE PROXIMAL TP AT THE ORIGIN OF THE ANTERIOR TIBIAL ARTERY. ANGIOGRAM SHOWED A RESIDUAL DISSECTION BETWEEN THE SECOND AND THIRD TACK. WITHOUT POST DILATING, A FORTH TACK WAS DEPLOYED BETWEEN THE SECOND AND THIRD TACK TO TREAT THE RESIDUAL DISSECTION. HOWEVER, AS THE PHYSICIAN WAS MANEUVERING THE DELIVERY SYSTEM THROUGH THE THIRD TACK, IT GOT CAUGHT AND MALFORMED THE TACKS. A BAILOUT STENT WAS PLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT IS BEING SUBMITTED DUE TO A BAILOUT STENT REQUIRED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386390 TACK ENDOVASCULAR SYSTEM SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. 156135061 275842 00863328000127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 6F GUIDE CATHETER UNK MFG| 6F INTRODUCER SHEATH UNK MFG| PHILIPS: 0.014" PHOENIX GUIDEWIRE