BEUDAMED
    FDA Adverse Event Death Summary report: N

    F/G WINGSPAN STENT SYSTEM 2.5 X 15MM

    MDR report key: 3801075 · Received May 8, 2014

    Report

    Report Number
    3008853977-2014-00149
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    February 20, 2014
    Report Date
    April 22, 2014
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINED IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE 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. HEMORRHAGE, STROKE, THROMBOSIS AND DEATH 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, A STENT WAS UNEVENTFULLY DEPLOYED AT THE LEVEL OF THE DISTAL RIGHT VERTEBRAL ARTERY (VA) AND BASILAR ARTERY (BA) STENOSIS. HOWEVER, THE PATIENT HAD A MAJOR BLEEDING IN THE RIGHT ILIAC JUNCTION AFTER STENT PLACEMENT, WHICH CAUSED THE PHYSICIAN TO STOP ANTICOAGULATION AND ANTIPLATELET THERAPY. THE PATIENT CLINICAL CONDITION DETERIORATED. THE PATIENT BECAME UNRESPONSIVE AND FAMILY AGREED UPON COMFORT MEASURES CARES. THE PATIENT WAS EXTUBATED AND FOUR DAYS POST PROCEDURE DIED. THE CAUSE OF DEATH WAS THE PROGRESSIVE OBTUNDATION, WHICH REQUIRED INTUBATION. SINCE IMAGING SHOWED EVIDENCE OF EXTENSIVE DIFFUSE EMBOLI THROUGHOUT THE POSTERIOR FOSSA, THIS RAISED THE POSSIBILITY OF EMBOLIC STROKE FROM A PROBABLE IN-STENT THROMBOSIS DUE TO ANTICOAGULATION WAS STOPPED AS THE PATIENT SUFFERED A MAJOR BLEEDING. THE PHYSICIAN STATED THAT THE PATIENT DEATH IS UNRELATED TO THE IMPLANTED STENT OR USAGE OF THE STENT DELIVERY SYSTEM DURING THE PROCEDURE.

    Description of Event or Problem · 1

    FOLLOWING ANGIOPLASTY, A STENT WAS UNEVENTFULLY DEPLOYED AT THE LEVEL OF THE DISTAL RIGHT VERTEBRAL ARTERY (VA) AND BASILAR ARTERY (BA) STENOSIS. HOWEVER, THE PATIENT HAD A MAJOR BLEEDING IN THE RIGHT ILIAC JUNCTION AFTER STENT PLACEMENT, WHICH CAUSED THE PHYSICIAN TO STOP ANTICOAGULATION AND ANTIPLATELET THERAPY. THE PATIENT CLINICAL CONDITION DETERIORATED. THE PATIENT BECAME UNRESPONSIVE AND FAMILY AGREED UPON COMFORT MEASURES CARES. THE PATIENT WAS EXTUBATED AND FOUR DAYS POST PROCEDURE DIED. THE CAUSE OF DEATH WAS THE PROGRESSIVE OBTUNDATION, WHICH REQUIRED INTUBATION. SINCE IMAGING SHOWED EVIDENCE OF EXTENSIVE DIFFUSE EMBOLI THROUGHOUT THE POSTERIOR FOSSA, THIS RAISED THE POSSIBILITY OF EMBOLIC STROKE FROM A PROBABLE IN-STENT THROMBOSIS DUE TO ANTICOAGULATION WAS STOPPED AS THE PATIENT SUFFERED A MAJOR BLEEDING. THE PHYSICIAN STATED THAT THE PATIENT DEATH IS UNRELATED TO THE IMPLANTED STENT OR USAGE OF THE STENT DELIVERY SYSTEM DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277598 F/G WINGSPAN STENT SYSTEM 2.5 X 15MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF 15836746

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death