BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIUM

    MDR report key: 8142473 · Received December 7, 2018

    Report

    Report Number
    2029214-2018-01031
    Event Type
    Death
    Date Received
    December 7, 2018
    Date of Event
    March 1, 2013
    Report Date
    December 7, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRD
    PMA / PMN Number
    K081465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF FUSIFORM AND DISSECTING BASILAR TRUNK ANEURYSMS WITH FLOW DIVERTERS, STENTS, AND COILS L.I. VAN OEL, W.J. VAN ROOIJ, M. SLUZEWSKI ET.AL (DOI.ORG/10.3174/AJNR.A3255). THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED; THEREFORE, NO EVALUATION CAN BE PERFORMED. THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER AN EVENT RELATED TO THE PATIENT'S CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THROUGH LITERATURE REVIEW THAT PATIENT EXPERIENCED ONE AFTER THE PROCEDURE SUBARACHNOID HEMORRHAGE (SAH) AND DIED THE NEXT DAY. THE PATIENT WAS PRESENTED WITH AN SAH OF HUNT AND HESS GRADE III. CT ANGIOGRAPHY SHOWED A GIANT ANEURYSM ON THE BASILAR ARTERY. ANGIOGRAPHY CONFIRMED THE PRESENCE OF A GIANT ANEURYSM ON AN ECTATIC AND ELONGATED BASILAR TRUNK, JUST DISTAL TO A PROXIMAL BASILAR FENESTRATION. THE PATIENT WAS TREATED WITH NON-MEDTRONIC STENT WAS PLACED VIA THE RIGHT VERTEBRAL ARTERY IN THE BASILAR TRUNK ACROSS THE ANEURYSMAL NECK. SUBSEQUENTLY, 1130 CM OF COILS WAS INSERTED IN THE ANEURYSMAL LUMEN, AND THE ANEURYSM APPEARED ADEQUATELY OCCLUDED. SEVERAL HOURS LATER, THE PATIENT DEVELOPED A RIGHT-SIDED HEMIPLEGIA. MR IMAGING THE NEXT DAY SHOWED A BRAIN STEM INFARCTION AND A SMALL CEREBELLAR INFARCTION ON THE RIGHT SIDE. THE PATIENT GRADUALLY NEUROLOGICALLY IMPROVED AND WAS DISCHARGED HOME 2 WEEKS LATER. FOUR WEEKS AFTER TREATMENT, SHE WAS FOUND COMATOSE AT HOME, AND A CT SCAN REVEALED A RECURRENT SAH. SHE DIED THE NEXT DAY. THERE WAS NO ALLEGATION OF ANY DEVICE MALFUNCTION ASSOCIATED WITH A MEDTRONIC DEVICE. AXIUM COILS WERE SUCCESSFULLY IMPLANTED IN ALL PATIENTS IN THIS LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981560 AXIUM DEVICE, EMBOLIZATION, VASCULAR KRD COVIDIEN (IRVINE) UNKNOWN NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death