BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3831192 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03332
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: SHEATH: COOK 6 FR SHORT. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE ARMADA 35 AND ABSOLUTE PRO REFERENCED ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RIGHT FEMORAL ARTERY CUTDOWN ACCESS APPROACH DURING A PROCEDURE OF THE MODERATELY CALCIFIED, NON-TORTUOUS, DE NOVO, MID POPLITEAL ARTERY, A COMPLETELY OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA) RETROGRADE LESION WAS OPENED AND A UNSPECIFIED AMPLATZ GUIDE WIRE WAS PLACED IN THE AORTA FOR ANGIOGRAPHY IMAGES. AFTER IMAGING, THE LEFT LEG WAS ACCESSED AND AN UNSPECIFIED DEVICE WAS ADVANCED TO THE RIGHT LEG FOR ADDITIONAL IMAGES OF THE SFA AND POPLITEAL AREAS. TWO 6 X 150 X 135 CM, AND ONE 6 X 80 X 135 CM ABSOLUTE PRO STENTS WERE SUCCESSFULLY IMPLANTED FROM THE RIGHT SFA DOWN TO THE DISTAL SFA BEING OVERLAPPED BY 1 CM EACH. A 6 X 250 X 80 CM ARMADA LL BALLOON DILATATION CATHETER (BDC) WAS ADVANCED RETROGRADE FROM THE CUTDOWN ACCESS FOR POST-DILATATION OF THE SFA STENTS. WHILE ADVANCING THE BDC THROUGH THE NON-ABBOTT SHORT SHEATH THE BDC DID NOT CROSS THROUGH THE STENTS; HIGH FORCE WAS USED AND THE BALLOON WAS ADVANCED ABOUT 5 CM THROUGH THE SHEATH BUT CAUGHT THE DEPLOYED STENTS AND STARTED TO MANGLE THE OVERLAP OF THE DISTAL TWO STENTS. THE BDC WAS SUCCESSFULLY REMOVED. A 6 X 14 MM NON-ABBOTT BDC WAS USED WITH THE NON-ABBOTT SHEATH AND PASSED THROUGH THE SHEATH AND WAS SUCCESSFULLY USED IN THE PROCEDURE WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308216 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF-EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention