BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACK ENDOVASCULAR SYSTEM (4F, 1.5 - 4.5MM)

    MDR report key: 12031330 · Received June 21, 2021

    Report

    Report Number
    3012608866-2021-00002
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 24, 2021
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    UDI-DI
    00863328000196
    PMA / PMN Number
    P180034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO INTACT VASCULAR FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PROCEDURE NOTES AND ANGIOGRAM IMAGING RECEIVED FROM THE CLINICAL SITE FROM THE (B)(6) 2021 PATIENT PROCEDURE INDICATED THE VESSEL MEASURED BY IVUS (RVD 5MM - 5.5MM), IN CONJUNCTION WITH THE BALLOONING OF THE VESSEL, RESULTED IN THE 4F SIZE TACK ENDOVASCULAR SYSTEM THAT WAS CHOSEN FOR USE TO BE UNDERSIZED FOR THE SIZE OF THE VESSEL AFTER ATHERECTOMY.

    Description of Event or Problem · 1

    THE REPORTER STATED "THE DEVICE WAS ORIGINALLY IMPLANTED (B)(6) 2021 AND TODAY THEY NOTICED DURING THE ANGIOGRAM THAT THE DEVICES HAVE MOVED. PRIOR TO AN INTERVENTION ON ANOTHER VESSEL ALTOGETHER." "IT WAS NOTICED THAT THE DEVICES HAD MOVED BETWEEN THIS PROCEDURE AND THE INITIAL PROCEDURE PERFORMED ON THE (B)(6) 2021." "IT IS IMPORTANT TO NOTE THAT THE MOVEMENT OF THESE DEVICES WERE NOTICED PRIOR TO ANY ADDITIONAL INTERNATIONAL MEASURES BEING TAKEN. BEFORE ANY WIRES REACHED THE STENT THEMSELVES. SOMETHING HAPPENED IN BETWEEN THE PROCEDURES AND CAUSED THE DEVICES TO MOVE. IT WAS NOTED VIA ANGIOGRAM DURING THE INITIAL RUN OFF BEFORE ANY WIRES WENT DOWN TO THE AREA." FOUR TACK ENDOVASCULAR DEVICES (TACKS) WERE IMPLANTED ON (B)(6) 2021 FOR TREATMENT OF A SIGNIFICANT SPIRAL DISSECTION IN THE TIBIAL PERONEAL TRUNK AS PART OF PURCUTANEOUS ATHERECTOMY PROCEDURE FOR A NON-HEALING ULCER OF LOWER EXTREMITY. POST-PROCEDURE ANGIOGRAMS ON (B)(6) 2021 SHOWED THE FOUR TACKS IMPLANTED PROPERLY AT THE DESIRED LOCATION IN THE VESSEL. ON A SUBSEQUENT ANGIOGRAM FROM (B)(6) 2021, THE THREE MOST DISTAL TACKS WERE SEEN IN ALTERED POSITIONS FROM THEIR ORIGINAL PLACEMENT. THREE TACKS APPEAR TO HAVE MOVED PROXIMAL TO THEIR ORIGINAL IMPLAINTATION SITES. IF ANY ADDITIONAL INFORMATION IS RECEIVED THAT HAS AN IMPACT ON WHAT IS CURRENTLY BEING REPORTED, A 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932339 TACK ENDOVASCULAR SYSTEM (4F, 1.5 - 4.5MM) TACK ENDOVASCULAR SYSTEM (4F, 1.4 - 4.5MM) QCT INTACT VASCULAR, INC. 240008 00863328000196

    Patients

    Seq Age Sex Outcome Treatment
    1 0.035 GUIDEWIRE / GLIDEWIRE| 2MM LASER CATHETER| 4MM SPIDER FILTER WIRE| 4X40MM BALLOON| 4X80MM BALLOON| 5F OMNI FLUSH CATHETER| 5F SHEATH| 5X220MM BALLOON| 6F MYNX VASCULAR CLSOURE DEVICE| 6F SHORT SHEATH| BERENSTEIN 6F SHEATH| IVUS