BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACK ENDOVASCULAR SYSTEM

    MDR report key: 19754738 · Received July 16, 2024

    Report

    Report Number
    3012608866-2024-00014
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 1, 2022
    Report Date
    July 16, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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/D10:THE EXACT DATE OF EVENT IS UNKNOWN; THUS, 6/1/2022 WAS LISTED AS THE DATE OF EVENT BASED ON THE DETAILS PROVIDED IN THE NATURE OF COMPLAINT. BLOCK B6/B7: PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. BLOCK D4/H4: THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION ARE UNKNOWN: MODEL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE BLOCK E: THE FACILITY CONTACT NAME, FACILITY SITE NAME, FACILITY PHONE NUMBER, AND FACILITY ADDRESS ARE UNKNOWN. BLOCK G4: THE MODEL NUMBER WAS NOT PROVIDED, THUS THE PMA NUMBER IS 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

    BLOCKS B1/B2/B5: FILING ADVERSE EVENT THAT WAS MISSED IN THE INITIAL MDR. BLOCK H1: UPDATING TO SERIOUS INJURY DUE TO THE INTERVENTION (FROM MALFUNCTION). BLOCK H6: THE TACK MIGRATED, REQUIRING ADDITIONAL INTERVENTION (STENT PLACEMENT). HEIC WAS UPDATED TO #4641 (FROM #2199). 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. DURING USE, A TACK MIGRATED WHILE MANEUVERING A SHEATH THROUGH THE TACK PRIOR TO POST DILATATION. THE USER HAD A HARD TIME DECIDING WHICH DISSECTIONS NEED TO BE TACKED VS STENTED, BUT DECIDED TO STENT IT. THERE WAS NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TACK MIGRATED. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TACK MIGRATED, REQUIRING ADDITIONAL INTERVENTION (STENT PLACEMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715053 TACK ENDOVASCULAR SYSTEM 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