BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3072020 · Received April 22, 2013

    Report

    Report Number
    3008853977-2013-00118
    Event Type
    Death
    Date Received
    April 22, 2013
    Date of Event
    January 1, 2010
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, HEMORRHAGE AND DEATH ARE NOTED IN THE DIRECTION FOR USE (DFU). THEREFORE, THE PROBABLE CAUSE OF THE EVENT IS ANTICIPATED PROCEDURAL COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    EVENT DATE: IT WAS REPORTED IN THE LITERATURE ARTICLE THAT THE REPORTED EVENT OCCURRED IN A SERIES OF PATIENT TREATED WITH NEUROFORM 3 OR NEUROFORM EZ BETWEEN JAN-2010 AND DEC-2011, THEREFORE THE EXACT DATE OF THE EVENT IS UNKNOWN. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A HEMORRHAGE WHILE THE NEUROFORM EZ WAS BEING PLACED VIA THE POSTERIOR COMMUNICATING ARTERY HORIZONTALLY ACROSS BOTH P1 SEGMENTS TO TREAT A BASILAR TIP ANEURYSM. THE CONTRALATERAL P1 WAS DIFFICULT TO CATHERTERIZE AND THE SUPERIOR CEREBELLAR ARTERY WAS ENTERED WITH THE WIRE AND MICROCATHETER SEVERAL TIMES. THE STENT WAS DEPLOYED. DESPITE NO OBVIOUS PROCEDURAL PERFORATION OR CONTRAST EXTRAVASATION, THE PATIENT HAD ASYMMETRICAL PUPILS WHILE EMERGING FROM ANESTHESIA. EMERGENT CT SHOWED DIFFUSE SAH; THE PATIENT DID NOT RECOVER AND DIED FOUR DAYS LATER. EXACT DATE OF DEATH WAS NOT REPORTED IN THE ARTICLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A HEMORRHAGE WHILE THE NEUROFORM EZ WAS BEING PLACED VIA THE POSTERIOR COMMUNICATING ARTERY HORIZONTALLY ACROSS BOTH P1 SEGMENTS TO TREAT A BASILAR TIP ANEURYSM. THE CONTRALATERAL P1 WAS DIFFICULT TO CATHETERIZE AND THE SUPERIOR CEREBELLAR ARTERY WAS ENTERED WITH THE WIRE AND MICROCATHETER SEVERAL TIMES. THE STENT WAS DEPLOYED. DESPITE NO OBVIOUS PROCEDURAL PERFORATION OR CONTRAST EXTRAVASATION, THE PATIENT HAD ASYMMETRICAL PUPILS WHILE EMERGING FROM ANESTHESIA. EMERGENT CT SHOWED DIFFUSE SAH; THE PATIENT DID NOT RECOVER AND DIED FOUR DAYS LATER. EXACT DATE OF DEATH WAS NOT REPORTED IN THE ARTICLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172464 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death