BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3072847 · Received April 23, 2013

    Report

    Report Number
    3008853977-2013-00127
    Event Type
    Death
    Date Received
    April 23, 2013
    Date of Event
    August 1, 2010
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED, THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEATH AND ANEURYSM BURST (RE-RUPTURE) ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PATIENT COMPLICATION.

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED BETWEEN (B)(6) 2001 AND (B)(6) 2010. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED BETWEEN (B)(6) 2001 AND (B)(6) 2010. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ARTICLE THAT THE PATIENT PRESENTED WITH A SUBARACHNOID HEMORRHAGE DUE TO THE ANEURYSM RUPTURE, UNDERWENT THE STENT ASSISTED EMBOLIZATION AND DIED DUE TO RERUPTURE OF THE ANEURYSM AFTER TREATMENT. THE PATIENT UNDERWENT THE PROCEDURE BETWEEN (B)(6) 2001 AND (B)(6) 2010. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ARTICLE THAT THE PATIENT PRESENTED WITH A SUBARACHNOID HEMORRHAGE DUE TO THE ANEURYSM RUPTURE, UNDERWENT THE STENT ASSISTED EMBOLIZATION AND DIED DUE TO RERUPTURE OF THE ANEURYSM AFTER TREATMENT. THE PATIENT UNDERWENT THE PROCEDURE BETWEEN (B)(6) 2001 AND (B)(6) 2010. THE EXACT DATE OF THE PROCEDURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173740 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF

    Patients

    Seq Age Sex Outcome Treatment
    1 Death