BEUDAMED
    FDA Adverse Event Death Summary report: N

    TARGET 360 ULTRA 2.5MM X 4CM

    MDR report key: 4792517 · Received May 22, 2015

    Report

    Report Number
    3008853977-2015-00220
    Event Type
    Death
    Date Received
    May 22, 2015
    Date of Event
    April 1, 2010
    Report Date
    May 1, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K102672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE EVENT IS UNKNOWN AS IT WAS FROM A RETROSPECTIVE REVIEW FROM PATIENTS ENROLLED FROM APRIL 2010 TO MARCH 2013. THE PRODUCT REMAINS IMPLANTED; THEREFORE, A PHYSICAL ANALYSIS COULD NOT BE PERFORMED. BECAUSE THE REPORTED EVENTS ARE KNOWN PHYSIOLOGICAL EFFECTS OF THE PROCEDURE NOTED WITH THE DIRECTIONS FOR USE AND/OR DEVICE LABELING, A CAUSE OF ANTICIPATED PATIENT COMPLICATION WAS ASSIGNED. THE SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL OF NEUROENDOVASCULAR THERAPY A CASE WHERE A PATIENT WITH A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WAS TREATED WITH 2 COILS (ONE WAS SUBJECT DEVICE AND THE OTHER WAS A NON-STRYKER COIL). THE ANEURYSM RE-RUPTURED 14 DAYS AFTER THE SURGERY AND THE PATIENT DIED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334251 TARGET 360 ULTRA 2.5MM X 4CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| O ED COIL 2X2 (NON-STRYKER)