BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 4916243 · Received July 9, 2015

    Report

    Report Number
    MW5044158
    Event Type
    Death
    Date Received
    July 9, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 23, 2015
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IN WHICH THE WINGSPAN STENT SYSTEM WAS USED EXPIRED BUT THE DEATH WAS NOT RELATED TO THE USE OF WINGSPAN DEVICE. IT IS BEING REPORTED TO THE WIRB AND THE SPONSOR PER HDE PROTOCOL. THE STENT AND ANGIOPLASTY PROCEDURE OF THE RIGHT INTERNAL CAROTID ARTERY WAS PERFORMED UNEVENTFULLY. THE PATIENT POST-PROCEDURE WAS KEPT IN THE ICU WITH A SYSTOLIC BLOOD PRESSURE GOAL OF LESS THAN 140. AT AROUND 6:00 P.M., PHYSICIAN WAS NOTIFIED FOR THE FIRST TIME BY THE NURSE THAT THE PATIENT IS BECOMING MORE LETHARGIC AND HAD UNEQUAL AND NONREACTIVE PUPIL. A STAT CT WAS ORDERED THAT DEMONSTRATING LARGE RIGHT INTRACRANIAL. HEMORRHAGE, MOSTLY IN THE PREVIOUS AREA OF THE STROKE CAUSING MIDLINE SHIFT OF AROUND 1.9 CM FROM RIGHT TO LEFT. BASED ON THE OVERALL PROGNOSIS OF THE PATIENT AND AFTER DISCUSSING ALL THE OPTIONS WITH THE FAMILY, THE FAMILY DECIDED FOR NOT TO PROCEED WITH ANY SURGICAL INTERVENTION, UNDERSTANDING THAT THE PROGNOSIS WOULD HAVE BEEN POOR IN NEUROSURGICAL INTERVENTION FOR ANY MEANINGFUL NEUROLOGICAL RECOVERY. THE FAMILY HAD DECIDED TO PROCEED WITH COMFORT CARE MEASURES ONLY AND REMOVED ALL ARTIFICIAL LIFE SUPPORT. ACCORDING TO THE PI THE DEATH WAS NOT RELATED TO THE USE OF THE WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER DEVICE AND WAS THE RESULT OF DISEASE PROCESS (REPERFUSION INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444782 WINGSPAN STENT SYSTEM WINGSPAN STENT NJE STRYKER NEUROVASCULAR NA 18013521

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death FINASTERIDE| PLAVIX| LIPITOR| ATENOLOL| GABAPENTIN| PROSCAR| MAGOXIDE