BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRYKER NEUROVASCULAR

    MDR report key: 8518264 · Received April 15, 2019

    Report

    Report Number
    8518264
    Event Type
    Death
    Date Received
    April 15, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 11, 2019
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD Y-STENT / COIL PROCEDURE FOR BASILAR ARTERY REMNANT ON (B)(6) 2019. PT CAME TO ED ON (B)(6) 2019 WITH SEVERE HEADACHE AND LOSS OF CONSCIOUSNESS. CTA: THROMBOSIS OF DISTAL VERTEBRAL AND BASILAR ARTERIES. PT WAS TREATED WITH THROMBECTOMY AND ANGIOPLASTY. ADMITTED TO ICU, PASSED AWAY ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309853 STRYKER NEUROVASCULAR NEUROFORM ATLAS STENT 4X24 NJE STRYKER NEUROVASCULAR SZAS4024 20296589

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death 22 COILS | HEADWAY 17 CATHETER | MICROVENTION LVIS JR (3.5X28) | NEUFORM ATLAS STENT | Y-STENT COILING