BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRYKER

    MDR report key: 3900299 · Received June 16, 2014

    Report

    Report Number
    3900299
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O FEMALE ADMITTED FOR AN ELECTIVE COIL EMBOLIZATION OF A MCA ANEURYSM ((B)(6) 2014), WITH POSSIBLE DEVICE MALFUNCTION WITH PREMATURE RELEASE OF COIL INTO THE MCA BRANCH REQUIRING DOUBLE STENTS. ON (B)(6) 2014, THE PT SUFFERED A SEVERE HEMORRHAGE INTO A CEREBRAL INFARCT COMPLICATED BY PLAVIX, ASPIRIN AND HEPARIN. A CRANIOTOMY AND DECOMPRESSION WERE PERFORMED WITH DEBRIDEMENT OF INFARCTED BRAIN TISSUE FROM WHICH SHE WAS UNABLE TO RECOVER. SHE DIED ON (B)(6) 2014. MFR REP (B)(4) NOTIFIED BY SURGICAL STAFF (B)(4) 2014. PT SAFETY DEPARTMENT VERIFIED THAT REP HAD BEEN NOTIFIED WITH CALL (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353129 STRYKER COIL TARGET 360 ULTRA HCG STRYKER NEUROVASCULAR 5MM X 10 CM 15781597

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death EXP 2/16, 6MM X20CM| STRYKER TARGET XL COIL: REF (B)(4), LOT #15907333,