BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)

    MDR report key: 10093192 · Received May 27, 2020

    Report

    Report Number
    3012608866-2020-00002
    Event Type
    Injury
    Date Received
    May 27, 2020
    Report Date
    May 27, 2020
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    UDI-DI
    00863328000103
    PMA / PMN Number
    P180034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO INTACT VASCULAR AT THE TIME OF THIS REPORT AND IS NOT EXPECTED TO BE RETURNED. INTACT VASCULAR HAS ATTEMPTED TO CONTACT THE REPORTER OF THIS EVENT FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED AFTER THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE ON (B)(6) 2020. TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM) WAS USED TO TREAT DISSECTIONS OBSERVED. DISPLACEMENT OF THE DEPLOYED TACK IMPLANT(S) WAS OBSERVED. DURING THE INDEX PROCEDURE ON (B)(6) 2020, THE PHYSICIAN DEPLOYED THREE TACK IMPLANTS IN RIGHT SUPERIOR FEMORAL ARTERY (SFA) AND FOLLOWED POST DILATATION OF THE TACK IMPLANTS, DISPLACEMENT OF THE TACK IMPLANT(S) WAS OBSERVED BY THE PHYSICIAN. THE PHYSICIAN THEN PROCEEDED TO DEPLOY ELUVIA DES WITHIN THE SFA AND OBSERVED ADDITIONAL TACK IMPLANT(S) DISPLACEMENT. UNSUCCESSFUL ATTEMPTS WERE MADE BY THE PHYSICIAN TO SNARE THE DISPLACED TACK IMPLANTS. THE PHYSICIAN COMPLETED THE PROCEDURE BY PERFORMING ANOTHER POST DILATATION STEP. THE CONCLUSION OF THE INDEX PROCEDURE, HAD THE TACK IMPLANT(S) DISPLACED FROM MID-SFA TO P1 REGION, ANGIOGRAPHY DEMONSTRATED GOOD BLOOD FLOW. THE PHYSICIAN DOCUMENTED REQUIRED PATIENT FOLLOW-UP WITH ULTRASOUND. PATIENT ULTRASOUND WAS TAKEN, AND THE PHYSICIAN DECIDED TO RE-INTERVENE BASED ON THE RESULTS OF THE ULTRASOUND ON (B)(6) 2020. THE RE-INTERVENTION INCLUDED USE OF JETSTREAM ATHERECTOMY FOLLOWED BY PROLONGED ANGIOPLASTY NEAR THE TACK IMPLANTED REGION. THE CONCLUSION OF THE (B)(6) 2020 PROCEDURE, HAD THE PHYSICIAN RECOMMENDING THE PATIENT TO VASCULAR SURGEON FOR SURGICAL REMOVAL OF THE TACK IMPLANT(S). INTACT VASCULAR REPRESENTATIVE WAS MADE AWARE OF THE INCIDENT ON (B)(6) 2020. VASCULAR SURGEON DR. BALJEET UPPAL OF (B)(6) PERFORMED EMBOLECTOMY AND ENDARTERECTOMY OF THE RIGHT POPLITEAL ARTERY, TIBIO-PERONEAL TRUNK PROXIMAL TIBIAL AND PERONEAL ARTERY ON (B)(6) 2020 AND EXPLANTED AT LEAST ONE OF THE TACK IMPLANT(S). THE SURGICAL INTERVENTION CONCLUDED WITH PATIENT RECEIVING SUCCESSFUL REVASCULARIZATION OF THE RIGHT LOWER EXTREMITY AND PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO INTACT VASCULAR AT THE TIME OF THIS REPORT AND IS NOT EXPECTED TO BE RETURNED. INTACT VASCULAR HAS ATTEMPTED TO CONTACT THE REPORTER OF THIS EVENT FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED AFTER THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE ON (B)(6) 2020. TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM) WAS USED TO TREAT DISSECTIONS OBSERVED. DISPLACEMENT OF THE DEPLOYED TACK IMPLANT(S) WAS OBSERVED. DURING THE INDEX PROCEDURE ON (B)(6) 2020, THE PHYSICIAN DEPLOYED THREE TACK IMPLANTS IN RIGHT SUPERIOR FEMORAL ARTERY (SFA) AND FOLLOWED POST DILATATION OF THE TACK IMPLANTS, DISPLACEMENT OF THE TACK IMPLANT(S) WAS OBSERVED BY THE PHYSICIAN. THE PHYSICIAN THEN PROCEEDED TO DEPLOY ELUVIA DES WITHIN THE SFA AND OBSERVED ADDITIONAL TACK IMPLANT(S) DISPLACEMENT. UNSUCCESSFUL ATTEMPTS WERE MADE BY THE PHYSICIAN TO SNARE THE DISPLACED TACK IMPLANTS. THE PHYSICIAN COMPLETED THE PROCEDURE BY PERFORMING ANOTHER POST DILATATION STEP. THE CONCLUSION OF THE INDEX PROCEDURE, HAD THE TACK IMPLANT(S) DISPLACED FROM MID-SFA TO P1 REGION, ANGIOGRAPHY DEMONSTRATED GOOD BLOOD FLOW. THE PHYSICIAN DOCUMENTED REQUIRED PATIENT FOLLOW-UP WITH ULTRASOUND. PATIENT ULTRASOUND WAS TAKEN, AND THE PHYSICIAN DECIDED TO RE-INTERVENE BASED ON THE RESULTS OF THE ULTRASOUND ON (B)(6) 2020. THE RE-INTERVENTION INCLUDED USE OF JETSTREAM ATHERECTOMY FOLLOWED BY PROLONGED ANGIOPLASTY NEAR THE TACK IMPLANTED REGION. THE CONCLUSION OF THE (B)(6) 2020 PROCEDURE, HAD THE PHYSICIAN RECOMMENDING THE PATIENT TO VASCULAR SURGEON FOR SURGICAL REMOVAL OF THE TACK IMPLANT(S). INTACT VASCULAR REPRESENTATIVE WAS MADE AWARE OF THE INCIDENT ON (B)(6) 2020. VASCULAR SURGEON DR. BALJEET UPPAL OF THE BANNER BOSWELL MEDICAL CENTER PERFORMED EMBOLECTOMY AND ENDARTERECTOMY OF THE RIGHT POPLITEAL ARTERY, TIBIO-PERONEAL TRUNK PROXIMAL TIBIAL AND PERONEAL ARTERY ON (B)(6) 2020 AND EXPLANTED AT LEAST ONE OF THE TACK IMPLANT(S). THE SURGICAL INTERVENTION CONCLUDED WITH PATIENT RECEIVING SUCCESSFUL REVASCULARIZATION OF THE RIGHT LOWER EXTREMITY AND PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557624 TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM) SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. NI NI 00863328000103

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention