BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19696745 · Received July 8, 2024

    Report

    Report Number
    3012608866-2024-00001
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    January 12, 2023
    Report Date
    July 25, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    UDI-DI
    00850003494036
    PMA / PMN Number
    P180034
    Adverse Event
    Yes
    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 A: THE PATIENT'S DOB OR AGE AT TIME OF EVENT, SEX, GENDER, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. BLOCK B6/B7: PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. BLOCK H3/H6: THE TACK DEVICE WAS NOT RETURNED, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    BLOCK G3: DATE RECEIVED BY MANUFACTURE UPDATED TO 6/24/2024 (FROM 6/24/2023). 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.

    Additional Manufacturer Narrative · 0

    BLOCK D4: UNIQUE IDENTIFIER (UDI#) UPDATED TO INCLUDE FULL UDI NUMBER. 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 THE SFA LESION. THREE TACKS WERE DEPLOYED INSIDE THE PATIENT; HOWEVER, ONE TACK WAS SLIGHTLY TILTED. IN ORDER TO ACHIEVE THE DESIRED OUTCOME, THE PHYSICIAN ELECTED TO STENT THE MOST DISTAL TACK, EVEN THOUGH LEAVING IT SLIGHTLY TILTED IN PLACE WAS NOT EXPECTED TO CAUSE ANY RISK OR HARM TO THE PATIENT. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY DUE TO THE TACK POSITION; RESULTING IN ELECTED STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134000 TACK ENDOVASCULAR SYSTEM (6F, 4.0-8.0MM) SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. 206135061 253321 00850003494036

    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.