BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACK ENDOVASCULAR SYSTEM

    MDR report key: 12962507 · Received December 8, 2021

    Report

    Report Number
    3012608866-2021-00006
    Event Type
    Injury
    Date Received
    December 8, 2021
    Date of Event
    November 1, 2020
    Report Date
    August 3, 2023
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    PMA / PMN Number
    P180034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. THE INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. THE LOT NUMBER WAS NOT AVAILABLE FROM THE FACILITY, THUS THE FOLLOWING INFORMATION ARE UNKNOWN: MODEL #, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. THE TACK DEVICE WAS DISCARDED BY THE FACILITY, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. THE IFU PRE-CAUTIONS TO USE A NEW BALLOON CATHETER FOR POST DILATATION OF THE SHORTEST LENGTH POSSIBLE.

    Additional Manufacturer Narrative · 0

    THE PATIENT''S DOB, 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. THE INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. THE LOT NUMBER WAS NOT AVAILABLE FROM THE FACILITY, THUS THE FOLLOWING INFORMATION ARE UNKNOWN: MODEL #, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. THE TACK DEVICE WAS DISCARDED BY THE FACILITY, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. THE IFU PRE-CAUTIONS TO USE A NEW BALLOON CATHETER FOR POST DILATATION OF THE SHORTEST LENGTH POSSIBLE.

    Additional Manufacturer Narrative · 0

    BLOCKS D1/ G1: MANUFACTURER ADDRESS WAS UPDATED FROM 1285 DRUMMERS LANE, SUITE 200, WAYNE, PA 19087 TO 5905 NATHAN LANE NORTH, PLYMOUTH, MN 55442. THIS CORRECTION WAS MADE TO ALIGN THE ADDRESS WITH THE FDA REGISTRATION NUMBER.

    Additional Manufacturer Narrative · 0

    BLOCKS D1/ G1: MANUFACTURER ADDRESS WAS UPDATED FROM 5905 NATHAN LANE NORTH, PLYMOUTH, MN 55442 TO 1285 DRUMMERS LANE, SUITE 200, WAYNE, PA 19087 TO MATCH THE INFORMATION ON THE PRODUCT LABEL.

    Description of Event or Problem · 0

    A 4-8 MM TACK DEVICE WAS USED TO TREAT A FLOW LIMITING DISSECTION IN THE MID POPLITEAL ARTERY VIA CONTRALATERAL APPROACH. THE TACKS DID NOT APPEAR TO FULLY OPEN; HOWEVER, POST DILATED SUCCESSFULLY WITH THE SAME BALLOON. THE PHYSICIAN NOTED THE TACKS APPEARED TO LAND MORE DISTAL; THEREFORE, TWO ADDITIONAL TACKS WERE DEPLOYED PROXIMAL TO THE OTHERS. THE SAME (UNWRAPPED) BALLOON WAS USED TO POST DILATE AND ENDED UP PUSHING ALL THE TACKS DOWNSTREAM. AS A RESULT, THE TACKS BUNCHED UP OBSTRUCTING THE BLOOD FLOW, THUS A SURGICAL BYPASS WAS CREATED AROUND THE TACKS. THE ANGIOGRAM WAS EMERGENTLY CONVERTED TO A LOWER EXTREMITY BYPASS, SECONDARY TO SEVERE ISCHEMIA / VESSEL THROMBOSIS. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE BUNCHED TACKS OBSTRUCTING BLOOD FLOW, REQUIRING SURGICAL INTERVENTION (BYPASS).

    Description of Event or Problem · 0

    A 4-8 MM TACK DEVICE WAS USED TO TREAT A FLOW LIMITING DISSECTION IN THE MID POPLITEAL ARTERY VIA CONTRALATERAL APPROACH. THE TACKS DID NOT APPEAR TO FULLY OPEN; HOWEVER, POST DILATED SUCCESSFULLY WITH THE SAME BALLOON. THE PHYSICIAN NOTED THE TACKS APPEARED TO LAND MORE DISTAL; THEREFORE, TWO ADDITIONAL TACKS WERE DEPLOYED PROXIMAL TO THE OTHERS. THE SAME (UNWRAPPED) BALLOON WAS USED TO POST DILATE AND ENDED UP PUSHING ALL THE TACKS DOWNSTREAM. AS A RESULT, THE TACKS BUNCHED UP OBSTRUCTING THE BLOOD FLOW, THUS A SURGICAL BYPASS WAS CREATED AROUND THE TACKS. THE ANGIOGRAM WAS EMERGENTLY CONVERTED TO A LOWER EXTREMITY BYPASS, SECONDARY TO SEVERE ISCHEMIA / VESSEL THROMBOSIS. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE BUNCHED TACKS OBSTRUCTING BLOOD FLOW, REQUIRING SURGICAL INTERVENTION (BYPASS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862001 TACK ENDOVASCULAR SYSTEM SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC.

    Patients

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