BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIUM PLATINUM 3D

    MDR report key: 4524396 · Received February 18, 2015

    Report

    Report Number
    2029214-2015-00164
    Event Type
    Death
    Date Received
    February 18, 2015
    Date of Event
    October 23, 2014
    Report Date
    January 21, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRD
    PMA / PMN Number
    K081465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THE LOT HISTORY RECORD REVIEWS OF THE REPORTED LOT NUMBERS SHOWED NO DISCREPANCIES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PHYSICIAN COMMENTED THAT THE SAH (SUBARACHNOID HEMORRHAGE) WAS ASSUMED TO BE CAUSED BY APPROACHING THE LESION REPEATEDLY WITH THE STENT DEVICE, PUSHED THE NARROWED VESSEL WITH THE STENT TIP AND THE PERFORATING BRANCH GOT TORN. AND THE HEMORRHAGE FROM THE VERTEBRAL ARTERY DUCT WAS ASSUMED TO BE CAUSED BY INFLATING THE BALLOON CATHETER REPEATEDLY TO CONTROL THE BLEEDING. HOWEVER, AS A RESULT OF RE-EVALUATING THE IMAGE, AT THE TIME OF THE ANGIOGRAPHY TAKEN WHEN THE GUIDING SHEATH WAS DELIVERED, THERE WAS ALREADY SMALL BLEEDING VISIBLE AT 2 POINTS, SO THE PHYSICIAN THOUGHT OF POSSIBILITY THAT THE CAUSE WAS HEMORRHAGE FROM THE PROGRESSIVE DISSOCIATION. IN ADDITION, THE PHYSICIAN CONCLUDED THAT THE CEREBRAL INFARCTION WAS CAUSED BY THE EMBOLIZATION TREATMENT FOR CONTROLLING THE SAH. THE PHYSICIAN ALSO NOTED ALL THE AXIUM DEVICES WORKED FINE. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: QC-4-12-3D, LOT: 9678056, DOM: 04 DEC 2012 EXP: 04 DEC 2015 (QTY. 2). MODEL: QC-4-12-HELIX, LOT: 9671348, DOM: 16 NOV 2012, EXP: 16 NOV 2015. MODEL: QC-3-8-HELIX, LOT: 9679170, DOM: 05 DEC 2012, EXP: 05 DEC 2015 (QTY. 2). MODEL: QC-4-12-HELIX, LOT: 9671348, DOM: 16 NOV 2012, EXP: 16 NOV 2015. MODEL: QC-5-20-HELIX, LOT: 9794832, DOM: 27 AUG 2013, EXP: 26 AUG 2016. MODEL: QC-5-20-HELIX, LOT: 9764798, DOM: 21 JUN 2013, EXP: 20 JUN 2016. MODEL: QC-8-30-HELIX, LOT: 9671150, DOM: 15 NOV 2012, EXP: 15 NOV 2015. MODEL: QC-8-30-HELIX, LOT: 9672545, DOM: 19 NOV 2012, EXP: 19 NOV 2015. MODEL: QC-6-20-HELIX, LOT: 9664685, DOM: 01 NOV 2012, EXP: 01 NOV 2015. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION REGARDING A PRODUCT. DURING AN EMERGENCY INTERVENTION, SEVERAL AXIUM COILS (QTY. 12) WERE USED TO EMBOLIZE A BLEEDING DUCT. POST PROCEDURE, THE PATIENT DEVELOPED A CEREBRAL INFARCTION. THE PATIENT EXPIRED ON (B)(6) 2014. PRIOR TO THE USE OF COILS, THE PHYSICIAN HAD ATTEMPTED TO ANGIOPLASTY THE VESSEL WITH A GATEWAY BALLOON AND PASS WINGSPAN STENT SEVERAL TIMES, BUT WITHOUT SUCCESS. THESE MULTIPLE ATTEMPTS CAUSED A BLEED IN THE VESSEL REQUIRING COIL EMBOLIZATION SINCE THE BALLOON WAS NOT ABLE TO CONTAIN THE BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116834 AXIUM PLATINUM 3D DEVICE, EMBOLIZATION, ARTERIAL KRD COVIDIEN (IRVINE) QC-6-20-3D 9673453

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death