BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ 3.5 X 30MM

    MDR report key: 7351607 · Received March 19, 2018

    Report

    Report Number
    3008881809-2018-00117
    Event Type
    Death
    Date Received
    March 19, 2018
    Date of Event
    December 1, 2012
    Report Date
    May 14, 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

    THE DEVICE REMAINS IN PATIENT.

    Additional Manufacturer Narrative · 1

    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; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. BASED ON THE ADDITIONAL INFORMATION PROVIDED THERE WAS NO ALLEGATION OF A MALFUNCTION WITH THE STENT. THE REPORTED PATIENT DEATH, THROMBOSIS AND STROKE ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE. THEREFORE, AN ASSIGNABLE CAUSE OF KNOWN INHERENT RISK OF PROCEDURE HAS BEEN ASSIGNED TO THE REPORTED PATIENT DEATH, THROMBOSIS AND STROKE.

    Description of Event or Problem · 1

    A PATIENT PRESENTED IN THE HOSPITAL PRIOR THE PROCEDURE WITH NEUROLOGICALLY INTACT BUT MULTIPLE BIOLOGICAL MORBIDITIES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERDENSITY IN THE AREA OF BASILAR ARTERY AND Y STENT AND MULTIPLE POSTERIOR CIRCULATION INFARCTS WITH OCCLUSION OF THE BASILAR ARTERY APPROXIMATELY FIVE MONTHS AFTER THE PROCEDURE OF STENTING FOR THE BASILAR APEX ANEURYSM. THE PATIENT WAS GIVEN INTEGRILIN AND RESTARTED PLAVIX AS A RESULT OF THE POST-PROCEDURE COMPLICATIONS. THEN APPROXIMATELY ONE MONTH LATER, THE PATIENT DECEASED FROM A STROKE. IN THE PHYSICIAN¿S OPINION THE OCCLUSION OF THE BASILAR ARTERY WAS DUE TO DISCONTINUATION OF PLAVIX AND RELATED TO THE SUBJECT DEVICE, THE PATIENT¿S DEATH WITH STROKE WAS POSSIBLY RELATED TO THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    A PATIENT PRESENTED IN THE HOSPITAL PRIOR THE PROCEDURE WITH NEUROLOGICALLY INTACT BUT MULTIPLE BIOLOGICAL MORBIDITIES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERDENSITY IN THE AREA OF BASILAR ARTERY AND Y STENT AND MULTIPLE POSTERIOR CIRCULATION INFARCTS WITH OCCLUSION OF THE BASILAR ARTERY APPROXIMATELY FIVE MONTHS AFTER THE PROCEDURE OF STENTING FOR THE BASILAR APEX ANEURYSM. THE PATIENT WAS GIVEN INTEGRILLIN AND RESTARTED PLAVIX AS A RESULT OF THE POST-PROCEDURE COMPLICATIONS. THEN APPROXIMATELY ONE MONTH LATER, THE PATIENT DECEASED FROM A STROKE. IN THE PHYSICIAN¿S OPINION THE OCCLUSION OF THE BASILAR ARTERY WAS DUE TO DISCONTINUATION OF PLAVIX AND RELATED TO THE SUBJECT DEVICE, THE PATIENT¿S DEATH WITH STROKE WAS POSSIBLY RELATED TO THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191894 NEUROFORM 3 EZ 3.5 X 30MM INTRACRANIAL NEUROVASCULAR STENT NJE STRYKER NEUROVASCULAR CORK 13528155

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| O| R