BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3854149 · Received June 6, 2014

    Report

    Report Number
    3008853977-2014-00177
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. 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. THROMBOSIS AND STROKE 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.

    Description of Event or Problem · 1

    FOLLOWING ANGIOPLASTY, TWO OVERLAPPING STENTS WERE PLACED TO COVER THE ENTIRE SEGMENT OF THE OCCLUDED RIGHT VERTEBRAL AND BASILAR ARTERIES. THE PATIENT AWOKE FROM ANESTHESIA WITHOUT NEW DEFICIT. HOWEVER, 15 HOURS AFTER THE PROCEDURE, THE PATIENT DEVELOPED SUDDEN ONSET OF RIGHT-SIDED WEAKNESS, NYSTAGMUS, AND RESPIRATORY FAILURE RELATED TO POSTERIOR FOSSA ISCHEMIA. IMAGING SHOWED A NON-OCCLUSIVE THROMBUS WITHIN THE PROXIMAL STENT. INTRA-ARTERIAL TISSUE PLASMINOGEN ACTIVATOR (2 MG) WAS ADMINISTERED VIA MICROCATHETER FOLLOWED BY SINGLE BOLUS (180 G/KG) AND MAINTENANCE INTRAVENOUS EPTIFIBATIDE. IMAGING SHOWED LYSIS OF THE THROMBUS. HOWEVER, FURTHER EVALUATION DEMONSTRATED THAT THERE WAS THE LOCAL CLOT FORMATION WITHIN THE STENT; THEREFORE, THE PATIENT WAS CONTINUED ON INTRAVENOUS EPTIFIBATIDE THERAPY (2 G/KG/MIN) FOR SEVERAL DAYS. THE SYMPTOMS OF NYSTAGMUS AND RIGHT-SIDED WEAKNESS QUICKLY RESOLVED AND FOLLOW-UP CT ANGIOGRAPHY 3 DAYS LATER REVEALED A WIDELY PATENT STENT AND RESOLUTION OF THE THROMBUS. THE PATIENT SPENT SEVERAL WEEKS IN HOSPITAL AND DISCHARGED WITHOUT FOCAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331296 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention WINGSPAN STENT (STRYKER)