BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ 3.5 X 20MM

    MDR report key: 6135930 · Received November 30, 2016

    Report

    Report Number
    3008881809-2016-00281
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    November 2, 2016
    Report Date
    February 14, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    UDI-DI
    04546540697806
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 1 OUT OF 4 REPORTS. THE SUBJECT DEVICE IS IMPLANTED.

    Additional Manufacturer Narrative · 1

    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 INFORMATION CURRENTLY AVAILABLE PATIENT¿S ANATOMY WAS NOTED TO BE VERY TORTUOUS/TENUOUS AND THE CUSTOMER USED ANOTHER DEVICE ANOTHER WHICH CAUSED THE STENT MIGRATION. THEREFORE, OPERATIONAL CONTEXT WAS ASSIGNED TO THE REPORTED ISSUE OF STENT MIGRATION. THE REPORTED PATIENT COMPLICATIONS 'PATIENT HEMORRHAGE', AND 'PATIENT DEATH' ARE KNOWN RISKS ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE A ROOT CAUSE OF ANTICIPATED PATIENT COMPLICATIONS HAS ALSO BEEN ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD AN UN-RUPTURED, WIDE-NECK, BASILAR TIP ANEURYSM, AND THE PHYSICIAN WANTED TO PLACE TWO ANEURYSM BRIDGING STENTS IN A Y-STENTING CONFIGURATION IN ORDER TO PERFORM COILING EMBOLIZATION. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO TRACK A MICROCATHETER THROUGH THE LUMEN OF THE IMPLANTED STENT (SUBJECT DEVICE), THE STENT MARKER BANDS MOVED DISTALLY. IN SPITE OF THE STENT MOVEMENT, THE PATIENT REMAINED IN STABLE CONDITION. THE PHYSICIAN ATTEMPTED TO ADVANCE A COMPETITOR MICROCATHETER OVER THE GUIDEWIRE THROUGH THE LUMEN OF THE STENT ENCOUNTERING RESISTANCE. THE PHYSICIAN COULD NOT CONFIRM IF THE COMPETITOR MICROCATHETER HAD ADVANCED THROUGH THE LUMEN OF THE IMPLANTED STENT; THEREFORE, A DYNA CT WAS PERFORMED TO CONFIRM POSITION OF THE COMPETITOR MICROCATHETER. THE PHYSICIAN WAS UNSUCCESSFUL IN CONFIRMING POSITION OF THE COMPETITOR MICROCATHETER; THEREFORE, REMOVED THE MICROCATHETER AND PROCEEDED TO ADVANCE A COMPETITOR BALLOON CATHETER OVER THE GUIDEWIRE. IT WAS REPORTED THAT DURING THE PROCESS OF ADVANCEMENT OF THE BALLOON AND GUIDEWIRE, THE PATIENT BECAME VERY HYPERTENSIVE. CONTRAST WAS INJECTED REVEALING AN EXTRAVASATION COMING FROM THE BASILAR TIP ANEURYSM AREA. THE PHYSICIAN REVERSED THE ANTIPLATELET MEDICATION AND COILED THE ANEURYSM. IN SPITE OF THE COIL EMBOLIZATION, THE EXTRAVASATION CONTINUED. THE PHYSICIAN ORDERED AN EXTERNAL VENTRICULAR DRAIN AND THE PATIENT WAS TRANSFERRED FOR A CT SCAN. IT WAS LATER REPORTED THAT THE PATIENT DIED. THE PHYSICIAN¿S OPINION OF THE PATIENT¿S OUTCOME OF DEATH IN RELATIONSHIP TO THE DEVICES WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT HAD AN UN-RUPTURED, WIDE-NECK, BASILAR TIP ANEURYSM, AND THE PHYSICIAN WANTED TO PLACE TWO ANEURYSM BRIDGING STENTS IN A Y-STENTING CONFIGURATION IN ORDER TO PERFORM COILING EMBOLIZATION. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO TRACK A MICROCATHETER THROUGH THE LUMEN OF THE IMPLANTED STENT (SUBJECT DEVICE), THE STENT MARKER BANDS MOVED DISTALLY. IN SPITE OF THE STENT MOVEMENT, THE PATIENT REMAINED IN STABLE CONDITION. THE PHYSICIAN ATTEMPTED TO ADVANCE A COMPETITOR MICROCATHETER OVER THE GUIDEWIRE THROUGH THE LUMEN OF THE STENT ENCOUNTERING RESISTANCE. THE PHYSICIAN COULD NOT CONFIRM IF THE COMPETITOR MICROCATHETER HAD ADVANCED THROUGH THE LUMEN OF THE IMPLANTED STENT; THEREFORE, A DYNA CT WAS PERFORMED TO CONFIRM POSITION OF THE COMPETITOR MICROCATHETER. THE PHYSICIAN WAS UNSUCCESSFUL IN CONFIRMING POSITION OF THE COMPETITOR MICROCATHETER; THEREFORE, REMOVED THE MICROCATHETER AND PROCEEDED TO ADVANCE A COMPETITOR BALLOON CATHETER OVER THE GUIDEWIRE. IT WAS REPORTED THAT DURING THE PROCESS OF ADVANCEMENT OF THE BALLOON AND GUIDEWIRE, THE PATIENT BECAME VERY HYPERTENSIVE. CONTRAST WAS INJECTED REVEALING AN EXTRAVASATION COMING FROM THE BASILAR TIP ANEURYSM AREA. THE PHYSICIAN REVERSED THE ANTIPLATELET MEDICATION AND COILED THE ANEURYSM. IN SPITE OF THE COIL EMBOLIZATION, THE EXTRAVASATION CONTINUED. THE PHYSICIAN ORDERED AN EXTERNAL VENTRICULAR DRAIN AND THE PATIENT WAS TRANSFERRED FOR A CT SCAN. IT WAS LATER REPORTED THAT THE PATIENT DIED. THE PHYSICIAN¿S OPINION OF THE PATIENT¿S OUTCOME OF DEATH IN RELATIONSHIP TO THE DEVICES WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785416 NEUROFORM 3 EZ 3.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK 18246874 04546540697806

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R XT-27 MICROCATHETER (STRYKER)