BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ 3.5 X 20MM

    MDR report key: 6147449 · Received December 6, 2016

    Report

    Report Number
    3008881809-2016-00288
    Event Type
    Death
    Date Received
    December 6, 2016
    Date of Event
    August 18, 2016
    Report Date
    March 1, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    UDI-DI
    04546540697806
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL TESTING COULD NOT BE PERFORMED. HOWEVER, THROMBOSIS AND DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENTING PROCEDURE WITH THE SUBJECT DEVICE AND A NON-STRYKER DEVICE, BOTH DEVICES THROMBOSED. ADMINISTRATION OF PHARMACOLOGICAL AGENTS TO CLEAR THE CLOTS WAS PERFORMED. THE PATIENT WAS PLACED IN PALLIATIVE CARE UNTIL DEATH OCCURED 3 DAYS POST-PROCEDURE. THE PHYSICIAN HAS ESTABLISHED THE RELATIONSHIP TO THE SUBJECT DEVICE AS SERIOUS, EXPECTED, RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENTING PROCEDURE WITH THE SUBJECT DEVICE AND A NON-STRYKER DEVICE, BOTH DEVICES THROMBOSED. ADMINISTRATION OF PHARMACOLOGICAL AGENTS TO CLEAR THE CLOTS WAS PERFORMED. THE PATIENT WAS PLACED IN PALLIATIVE CARE UNTIL DEATH OCCURED 3 DAYS POST-PROCEDURE. THE PHYSICIAN HAS ESTABLISHED THE RELATIONSHIP TO THE SUBJECT DEVICE AS SERIOUS, EXPECTED, RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799735 NEUROFORM 3 EZ 3.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 18330260 04546540697806

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R ENTREPRISE STENT (B)(4)