BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 MICRODELIVERY STENT SYSTEM

    MDR report key: 1001942 · Received February 20, 2008

    Report

    Report Number
    2939204-2008-00047
    Event Type
    Injury
    Date Received
    February 20, 2008
    Report Date
    January 21, 2008
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: VORA, N., THOMAS, A., GERMANWALA, A., JOVIN, T., & HOROWITZ, M. "RETRIEVAL OF A DISPLACED DETACHABLE COIL AND INTRACRANIAL STENT WITH AN L5 MERCI RETRIEVE DURING ENDOVASCULAR EMBOLIZATION OF AN INTRACRANIAL ANEURYSM." J NEUROIMAGING 2008;18:81-84. FOLLOW UP RESPONSES FROM THE PHYSICIAN STATED THAT THE SUBJECT DEVICE (STENT) DID NOT "ADVERSELY AFFECTED THIS CASE IN ANY WAY." IT WAS SUCCESSFULLY PLACED WITHOUT ISSUE. AS WELL, "THE CAUSE OF THE ADVERSE EVENT WAS THE ANEURYSM PERFORATION AND INABILITY TO CONTROL THIS PERFORATION WITH COILS," AND WAS UNRELATED TO THE SUBJECT DEVICE. FINALLY, THE PHYSICIAN STATED THAT "WE FELT THAT THIS WAS AN EV3 COIL ISSUE." BASED ON THE INFO KNOWN AT THIS TIME, BOSTON SCIENTIFIC HAS DETERMINED THE CAUSE OF THE REPORTED DIFFICULTIES TO BE OPERATIONAL CONTEXT (I.E., OPERATIONAL CONTEXT CONTRIBUTED TO EVENT). BECAUSE THE SUBJECT DEVICE WAS SUCCESSFULLY PLACED WITHOUT INCIDENT, AND BECAUSE FOLLOW UP RESPONSES SUGGESTED THAT THE ISSUE WAS RELATED TO THE COIL, IT APPEARS THAT THE REPORTED DEVICE ISSUE OCCURRED AS THE SUBJECT DEVICE WAS SUBJECTED TO CONDITIIONS WHICH EXCEEDED ITS CAPABILITIES.

    Description of Event or Problem · 1

    IN A REVIEW OF LITERATURE, IT WAS NOTED ON 1/21/08, THAT IN A PROCEDURE OCCURRING IN 2006, "A MAN SUSTAINED INJURIES FROM A MOTOR VEHICLE CRASH AFTER LOSING CONSCIOUSNESS WHILE DRIVING. COMPUTED TOMOGRAPHY OF THE HEAD REVEALED SUBARACHNOID HEMORRHAGE. THE PT HAD A HUNT AND HESS SCORE OF IV AND WAS TRANSFERRED TO OUR INSTITUTION FOR FURTHER MANAGEMENT INCLUDING VENTRICULOSTOMY. A CEREBRAL ANGIOGRAM DEMONSTRATED BILATERAL INTERNAL CAROTID ARTERY DISSECTIONS AND AN 8.5-MM, FUSIFORM VERTEBRAL CONFLUENCE ANEURYSM FELT TO BE RESPONSIBLE FOR THE PT'S SUBARACHNOID HEMORRHAGE." "THE PT WAS GIVEN 5,000 UNITS OF HEPARIN INTRAVENOUSLY TO MAINTAIN AN ACTIVATED CLOTTING TIME [GREATER THAN OR EQUAL TO] 250 SECONDS." A COIL WAS PARTIALLY DEPLOYED WITHIN THE ANEURYSM TO ANCHOR THE MICROCATHETER. A 4.5MMX30MM STENT (SUBJECT DEVICE) WAS DEPLOYED ACROSS THE ANEURYSM NECK, JAILING THE MICROCATHETER AND COIL IN PLACE. "THE COIL WAS THEN ADVANCED FURTHER INTO THE BODY OF THE ANEURYSM BUT FAILED TO POSITION PROPERLY." WHILE REMOVING THE COIL, IT ENTANGLED IN THE SUBJECT DEVICE, AND "BOTH DEVICES WERE PULLED TOGETHER PROXIMALLY INTO THE INTRADURAL VERTEBRAL ARTERY." A SNARE WAS USED TO RETRIEVE THE COIL AND SUBJECT DEVICE. A FEMORAL ARTERY RUN SHOWED THAT THE DISTAL HELICAL COIL OF THE SNARE AND DISTAL END OF THE SUBJECT DEVICE HAD FRACTURED," PRESUMABLY DURING FINAL EXTRACTION, AND REMAINED WITHIN THE FEMORAL ARTERY. HOWEVER, NO FOREIGN BODIES REMAINED IN THE LEFT VERTEBRAL ARTERY OR BASILAR ARTERY AFTER THIS RETRIEVAL. FURTHERMORE, THERE WAS NO EVIDENCE OF CATHETER SPASM WITHIN THE PARENT ARTERY OR DISSECTION, AND THE ANEURYSM WAS STABLE FOR RECATHETERIZATION." AS THE VESSEL DIAMETER WAS UNDERESTIMATED, A LARGER STENT WAS PLACED AND THE ANEURYSM WAS CATHETERIZED AND COILED. "HOWEVER, INTERVAL POSTCOILING RUNS DEMONSTRATED CONTRAST EXTRAVASATION FROM THE ANEURYSM." "HEPARIN WAS REVERSED WITH BOLUSED INTRAVENOUS PROTAMINE. A SECOND VENTRICULOSTOMY WAS IMMEDIATELY PLACED WHEN THE FIRST VENTRICULAR DRAIN MALFUNCIONED. A BALLOON WAS INFLATED IN THE LEFT VERTEBRAL ARTERY TO PARTIALLY ARREST POSTERIOR CIRCULATION FLOW WHILE THE ANEURYSM WAS ADDITIONALLY COILED. EXTRAVASATION, HOWEVER, CONTINUED." SUCCESSFUL OCCLUSION OF THE LEFT VERTEBRAL ARTERY WAS PERFORMED, AND "REPEAT RUNS THROUGH THE LEFT VERTEBRAL ARTERY DID NOT SHOW ANY FLOW TO THE ANEURYSM OR BASILAR ARTERY. FLOW INTO THE BASILAR ARTERY WAS NOTED VIA A RIGHT VERTEBRAL ARTERY INJECTION." PRIOR TO REMOVING THE ENTIRE SYSTEM, A COMMON FEMORAL ARTERY RUN REVEALED THE FRACTURED SNARE AND STENT WITH SOME THROMBUS FORMATION. "THE PT WAS SUBSEQUENTLY TRANSFERRED BACK TO THE NEUROINTENSIVE CARE UNIT AND WAS DECLARED BRAIN DEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 MICRODELIVERY STENT SYSTEM NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R 6 OCCLUSION COILS| MICROCATHETER| COIL| NON-BSC| GUIDEWIRE| GUIDE CATHETER| HEPARIN| PROTAMINE| BSC| SNARE| GUIDEWIRE| CORONARY STENT