BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10614092 · Received October 1, 2020

    Report

    Report Number
    3012608866-2020-00003
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    August 24, 2020
    Report Date
    September 25, 2020
    Manufacturer
    INTACT VASCULAR INC.
    Product Code
    QCT
    UDI-DI
    00863328000103
    PMA / PMN Number
    P180034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    NON-COMPLIANT PATIENT UNDERWENT MULTIPLE ENDOVASCULAR INTERVENTIONS. TACK IMPLANTATION PROCEDURE OCCURRED ON (B)(6) 2020. THIS PROCEDURE WAS PERFORMED 12 MONTHS POST ATHERECTOMY AND DCB INTERVENTION AS PATIENT RETURNED WITH RECURRENT SYMPTOMS. PATIENT RECEIVED 9 (NINE) TACK IMPLANTS AND END RESULT OF THE PROCEDURE SHOWED DISSECTIONS TREATED WITH GOOD FLOW. PATIENT RETURNED 7.5 MONTHS LATER ON (B)(6) 2020 WITH SYMPTOMATIC PAIN AND WAS FOUND TO HAVE THE PRIOR TREATED SUPERIOR FEMORAL ARTERY (SFA) OCCLUDED INCLUDING THE TACK IMPLANTED REGION (DISTAL SFA TO P2). PHYSICIAN OBSERVED THE PATIENT WAS STILL NON-COMPLIANT (CONTINUED SMOKING AND NOT TAKING PRESCRIBED MEDICATION). PHYSICIAN DECIDED TO PERFORM ANOTHER ENDOVASCULAR PROCEDURE AND USED PENUMBRA CAT 8 & 6 DEVICES AND FOLLOWED WITH USE OF ANGIOJET AND ENDED THE PROCEDURE WITH USE OF MEDTRONIC SE STENT OVER ALL TACK IMPLANTS. AT THE END OF THE PROCEDURE, ONE OUT OF THE NINE TACK IMPLANTS WAS OBSERVED TO BE DISPLACED IN ANTERIOR TIBIAL REGION. PHYSICIAN CONCLUDED THE PROCEDURE STATING, NO FURTHER INTERVENTION NECESSARY. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AND IS VIABLE FOR FUTURE FEMORAL/TIBIAL BYPASS PROCEDURE OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082294 TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM) TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM) QCT INTACT VASCULAR INC. 6F 00863328000103

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ANGIO-JET| CHOCOLATE PTA (3.5 & 5.0MM)| INPACT DCB (5.0&6.0MM)| MEDTRONIC STENT SE| PENUMBRA CAT 8.0 & 6.0