BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ 4.0 X 30MM

    MDR report key: 7356267 · Received March 20, 2018

    Report

    Report Number
    3008881809-2018-00126
    Event Type
    Death
    Date Received
    March 20, 2018
    Date of Event
    June 24, 2015
    Report Date
    May 22, 2018
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEATH DATE - ADDED. EXPIRATION DATE - ADDED. MANUFACTURING DATE - ADDED. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE PHYSICAL AND FUNCTIONAL TESTS COULD NOT BE PERFORMED. HOWEVER, PATIENT THROMBOSIS AND PATIENT DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF KNOWN INHERENT RISK OF PROCEDURE WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DELIVERY AND COILING WENT AS EXPECTED DURING PROCEDURE BUT THE STENT CLOTTED DESPITE HEPARIN USE CAUSING COMPLETE THROMBOSIS OF THE LEFT POSTERIOR CEREBRAL ARTERY (PCA). A THROMBECTOMY WAS PERFORMED AND THE STENT WAS REMOVED BUT THE PATIENT WAS WITHDRAWN FROM CARE ONE WEEK LATER AND DIED. ACCORDING TO THE PHYSICIAN, THE THROMBOSIS/DEATH WAS LIKELY RELATED TO A COMBINATION OF THE DEVICE AND PATIENT'S BASELINE MORBIDITIES RELATED TO PREVIOUS STROKE DEFICITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DELIVERY AND COILING WENT AS EXPECTED DURING PROCEDURE BUT THE STENT CLOTTED DESPITE HEPARIN USE CAUSING COMPLETE THROMBOSIS OF THE LEFT POSTERIOR CEREBRAL ARTERY (PCA). A THROMBECTOMY WAS PERFORMED AND THE STENT WAS REMOVED BUT THE PATIENT WAS WITHDRAWN FROM CARE ONE WEEK LATER AND DIED. ACCORDING TO THE PHYSICIAN, THE THROMBOSIS/DEATH WAS LIKELY RELATED TO A COMBINATION OF THE DEVICE AND PATIENT'S BASELINE MORBIDITIES RELATED TO PREVIOUS STROKE DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198033 NEUROFORM 3 EZ 4.0 X 30MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 17467672

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| O| R