BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ 4.5 X 20MM

    MDR report key: 5377463 · Received January 19, 2016

    Report

    Report Number
    3008853977-2016-00018
    Event Type
    Death
    Date Received
    January 19, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 21, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, VESSEL THROMBOSIS, HEMORRHAGE, AND DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    EVENT DATE AND DEATH DATE: THE EXACT DATES OF THE ADVERSE EVENTS ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RECURRING PARACLINOID ANEURYSM. THE PATIENT WAS TREATED WITH ANOTHER MANUFACTURER'S COILS AND A STENT (SUBJECT DEVICE). DURING THE PROCEDURE, IT WAS REPORTED THAT COIL LOOP HERNIATIONS FORMED WITH SUBSEQUENT THROMBOEMBOLIC COMPLICATIONS FOR WHICH REOPRO WAS ADMINISTERED. THE PATIENT WAS DISCHARGED PER STANDARD PROTOCOL. APPROXIMATELY THREE DAYS POST PROCEDURE, THE PATIENT SUFFERED FROM A LARGE HEMORRHAGE AND LATER DIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RECURRING PARACLINOID ANEURYSM. THE PATIENT WAS TREATED WITH ANOTHER MANUFACTURER'S COILS AND A STENT (SUBJECT DEVICE). DURING THE PROCEDURE, IT WAS REPORTED THAT COIL LOOP HERNIATIONS FORMED WITH SUBSEQUENT THROMBOEMBOLIC COMPLICATIONS FOR WHICH REOPRO WAS ADMINISTERED. THE PATIENT WAS DISCHARGED PER STANDARD PROTOCOL. APPROXIMATELY THREE DAYS POST PROCEDURE, THE PATIENT SUFFERED FROM A LARGE HEMORRHAGE AND LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35095 NEUROFORM 3 EZ 4.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R