BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 5446091 · Received February 18, 2016

    Report

    Report Number
    2024168-2016-00970
    Event Type
    Death
    Date Received
    February 18, 2016
    Date of Event
    March 18, 2015
    Report Date
    May 9, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RETURN STATUS CORRECTED. THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WAS NOT PROVIDED THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY AND PATIENT EFFECTS; HOWEVER THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DESCRIBE EVENT OF PROBLEM CONTINUED: THE DEVICES WERE REMOVED, BUT THE PATIENT NEVER RECOVERED AND PASSED AWAY 6 DAYS LATER ON (B)(6) 2015. REPORTEDLY WHEN THE DEVICES WERE RETURNED TO THE NON-ABBOTT COMPANY, THE BMW GUIDE WIRE WAS ALSO FOUND TO BE INTERTWINED WITH THE STENT AND SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS: GUIDE WIRE: GLIDEWIRE ADVANTAGE; SHEATH: 6X45 CM COOK FLEXOR ANSEL GUIDING SHEATH; ATHERECTOMY: 1.4 TYRBO ELITE LASER; STENT: BOSTON SCIENTIFIC EPIC VASCULAR SELF-EXPANDING STENT. IT IS UNKNOWN IF THE DEVICE IS RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO FACILITATE LIMB SALVAGE. ANGIOGRAMS OF THE LEFT LEG SHOWED A NEAR OCCLUSION IN THE DISTAL LEFT EXTERNAL ILIAC AND PROXIMAL COMMON FEMORAL ARTERY, SEVERE DISEASE IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA), A SUBTOTAL OCCLUSION IN THE LEFT POPLITEAL, MULTIPLE SEQUENTIAL SUBTOTAL OCCLUSIONS OF THE LEFT ANTERIOR TIBIAL AND A 90% LESION IN THE LEFT PERONEAL. A 6 X 45 CM SHEATH WAS PLACED IN THE EXTERNAL ILIAC ARTERY. A NON-ABBOTT GUIDE WIRE WAS PLACED IN THE LEFT SFA AND A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS PLACED INTO THE DISTAL LEFT PERONEAL ARTERY. A 5 X 40 MM BALLOON WAS USED IN THE DISTAL EXTERNAL ILIAC LESION TO FACILITATE FLOW DOWN THE LEG. LASER ATHERECTOMY WAS DONE IN THE LEFT PERONEAL, THE POPLITEAL AND THE PROXIMAL SFA. BALLOONING WAS DONE IN THE PERONEAL, POPLITEAL AND THE PROXIMAL SFA WITH NICE RESULT. DUE TO RESIDUAL STENOSIS OF > 50% IN THE LEFT EXTERNAL ILIAC, BAILOUT STENTING WAS ATTEMPTED WITH AN 8 X 40 MM NON-ABBOTT SELF-EXPANDING STENT. THE DEVICE WAS POSITIONED, BUT INITIAL DEPLOYMENT OF THE STENT RESULTED IN SEVERE DEFORMITY. DESPITE MULTIPLE MANIPULATIONS OF THE DELIVERY SYSTEM, THE STENT ONLY PARTIALLY DEPLOYED. USING ACCESS ON THE LEFT SUPERFICIAL FEMORAL ARTERY, A NON-ABBOTT GUIDE WIRE WAS ABLE TO TRAVERSE THE DEFORMED SEGMENT OF THE STENT BACK UP INTO THE ABDOMINAL AORTA. THE STENT REMAINED SEVERELY DEFORMED AND WAS UNABLE TO MANIPULATE BY PUSHING OR PULLING THE STENT DELIVERY SYSTEM OR THE SHEATH. AT THIS POINT, IT WAS THOUGHT THAT THE DELIVERY SYSTEM OR SHEATH COULD NOT BE SAFELY REMOVED, SO THE PATIENT WAS TAKEN FOR SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101052 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death