BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCAFFOLD, DISSECTION REPAIR

    MDR report key: 23043385 · Received September 12, 2025

    Report

    Report Number
    3012608866-2025-00001
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    January 3, 2025
    Report Date
    September 12, 2025
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A: THE PATIENT'S DOB OR AGE AT TIME OF EVENT, SEX, GENDER, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. BLOCK B3/D6A/D10: THE DATE OF EVENT WAS NOT PROVIDED, THUS (B)(6) 2025 WAS LISTED. BLOCK B6/B7: PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. BLOCK D1: THE BRAND NAME IS UNKNOWN; HOWEVER, THE AFFECTED DEVICE IS FOR THE TACK ENDOVASCULAR SYSTEM. BLOCK D4/G4/H4: THE LOT NUMBER WAS NOT PROVIDED; THUS, THE FOLLOWING INFORMATION ARE UNKNOWN: BRAND NAME, MODEL NUMBER, CATALOG NUMBER, UNIQUE ID, EXPIRATION DATE, MANUFACTURE DATE, AND PMA NUMBER. BLOCK H3: THE TACK DEVICE WAS NOT RETURNED; THUS, NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BLOCK H6: PER THE IFU, TACK IMPLANT OCCLUSION/RESTENOSIS IS LISTED AS A POSSIBLE COMPLICATION OF THE PROCEDURE. 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. ACCORDING TO A POST SHARED ON LINKEDIN, THE USER WAS UNABLE TO CROSS THE SFA DUE TO THE TACK STENTS. THEREFORE, AN ENDOVASCULAR BYPASS WAS PERFORMED TO ACCESS THE LESION, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS ADVERSE EVENT IS BEING SUBMITTED DUE TO RE-OCCLUSION, REQUIRING ENDOVASCULAR BYPASS TO TREAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169937 SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK MFG AND SIZE: GUIDE CATHETER| UNK MFG AND SIZE: GUIDE WIRE| UNK MFG AND SIZE: INTRODUCER SHEATH