BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 - 3.0 X 15MM

    MDR report key: 4339771 · Received December 18, 2014

    Report

    Report Number
    3008853977-2014-00399
    Event Type
    Death
    Date Received
    December 18, 2014
    Date of Event
    July 20, 2008
    Report Date
    December 12, 2014
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. BECAUSE THE REPORTED EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITH THE DIRECTIONS FOR USE AND/OR DEVICE LABELING, A CAUSE OF ANTICIPATED PATIENT COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT (SUBJECT DEVICE) ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. NINE DAYS POST PROCEDURE, THE PATIENT DEVELOPED HEMORRHAGIC REORGANIZATION OF THE RIGHT HEMISPHERE. HOSPITALIZATION WAS PROLONGED AND MEDICATION WAS GIVEN. THE PATIENT'S CLINICAL STATUS WORSENED APPROXIMATELY ONE MONTH POST PROCEDURE AND THE PATIENT EXPIRED APPROXIMATELY TWO MONTHS POST PROCEDURE. THE RELATIONSHIP TO THE STENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT, HOSPITALIZED FOR APPROXIMATELY ONE MONTH BECAUSE OF A RUPTURED ANEURYSM FOLLOWED BY NEUROLOGICAL DETERIORATION AND CRANIECTOMY AND LEFT HEMIPLEGIA, UNDERWENT SUCCESSFUL STENT (SUBJECT DEVICE) ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. THE MODIFIED RANKIN SCALE WAS 4 BEFORE AND AFTER THE PROCEDURE. NINE DAYS POST PROCEDURE, THE PATIENT DEVELOPED HEMORRHAGIC REORGANIZATION OF THE RIGHT HEMISPHERE. AS THE HEMORRHAGIC REORGANIZATION TOOK PLACE AWAY FROM THE ANEURYSM, THE HEMORRHAGIC REORGANIZATION APPEARED TO CORRESPOND TO A ¿BARRIER BREAKING INJURY WORSENED BY ANTIPLATELET MEDICATION¿. HOSPITALIZATION WAS PROLONGED AND MEDICATION WAS GIVEN. THE PATIENT'S CLINICAL STATUS WORSENED APPROXIMATELY ONE MONTH POST PROCEDURE AND THE PATIENT EXPIRED APPROXIMATELY TWO MONTHS POST PROCEDURE. THE CAUSE OF DEATH WAS NOTED TO BE SEPTICEMIA AND THE RELATIONSHIP TO THE STENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT, HOSPITALIZED FOR APPROXIMATELY ONE MONTH BECAUSE OF A RUPTURED ANEURYSM FOLLOWED BY NEUROLOGICAL DETERIORATION AND CRANIECTOMY AND LEFT HEMIPLEGIA, UNDERWENT SUCCESSFUL STENT (SUBJECT DEVICE) ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. THE MODIFIED RANKIN SCALE WAS 4 BEFORE AND AFTER THE PROCEDURE. NINE DAYS POST PROCEDURE, THE PATIENT DEVELOPED HEMORRHAGIC REORGANIZATION OF THE RIGHT HEMISPHERE. AS THE HEMORRHAGIC REORGANIZATION TOOK PLACE AWAY FROM THE ANEURYSM, THE HEMORRHAGIC REORGANIZATION APPEARED TO CORRESPOND TO A ¿BARRIER BREAKING INJURY WORSENED BY ANTIPLATELET MEDICATION¿. HOSPITALIZATION WAS PROLONGED AND MEDICATION WAS GIVEN. THE PATIENT'S CLINICAL STATUS WORSENED APPROXIMATELY ONE MONTH POST PROCEDURE AND THE PATIENT EXPIRED APPROXIMATELY TWO MONTHS POST PROCEDURE. THE CAUSE OF DEATH WAS NOTED TO BE SEPTICEMIA AND THE RELATIONSHIP TO THE STENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832430 NEUROFORM 3 - 3.0 X 15MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF 11345528

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death BARE COILS (48CM, MANUFACTURER UNKNOWN)