BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXUS DETACHABLE COIL

    MDR report key: 1270089 · Received December 18, 2008

    Report

    Report Number
    2029214-2008-00273
    Event Type
    Death
    Date Received
    December 18, 2008
    Date of Event
    July 19, 2006
    Report Date
    July 3, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS CONSUMED IN THE EVENT. ENDECOR REGISTRY INFORMATION. FOREIGN REGISTRY PERTAINING TO THE EVALUATION OF NEXUS DETACHABLE COILS IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. PROSPECTIVE, MULTI-CENTER IN FOREIGN COUNTRIES, ENROLLMENT STARTED IN 2006; ENROLLMENT CLOSED IN 2007. N = 404; PATIENTS COMPLETING 1 YEAR FOLLOW-UP. MDR NUMBERS: 2029214-2008-00262 TO 2029214-2008-00312.

    Description of Event or Problem · 1

    INFORMATION FROM CLINICAL TRIAL DATABASE. ON THE 3RD DAY POST-SAH, STABLE NEUROLOGICAL CONDITION AND ROUTINE BRAIN CT SHOWED KNOWN SAH BU NO ISCHEMIC INFARCTS. ON THE 5TH DAY POST-SAH, SUDDEN COMA, BILATERAL MYDRIASIS. CT SHOWED BILATERAL A2 INFARCTS POSSIBLY DUE TO VASOSPASM. INTUBATED, TRANSFERRED TO ICU AND DECLARED BRAIN DEAD ON THE 8TH DAY POST-SAH. COILS USED: MODEL: X-4-10-T10-HSS, PRODUCT NAME: NEXUS HELIX SUPERSOFT CSR. X-3-8-T10-HSS, NEXUS HELIX SUPERSOFT CSR. X-2-6-T10-HSS, NEXUS HELIX SUPERSOFT CSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR X-4-10-T10-HSS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death