BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT DELIVERY SYSTEM

    MDR report key: 915763 · Received September 17, 2007

    Report

    Report Number
    6000078-2007-00231
    Event Type
    Death
    Date Received
    September 17, 2007
    Report Date
    August 22, 2007
    Manufacturer
    NEURVOCASULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. FOLLOW UP REQUESTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007, A BASILAR STROKE TREATMENT PROCEDURE OF A MALE, WITH UNCONTROLLED HYPERTENSION AND DIABETES MELLITUS. THE PT WAS DIAGNOSED WITH LEFT HEMIPLEGIA, REFERRED FROM ANOTHER FACILITY MORE THAN 3 HOURS SINCE SYMPTOM ONSET. THE "PT" PROGRESSED AND BECAME QUADRIPLEGIC, BUT DID NOT BECOME COMATOSE." AN MRI (MAGNETIC RESONANCE IMAGING) WAS NOT PERFORMED. CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) REVEALED AN 18MM LONG LEFT BASILAR OCCLUSION. THE PT WAS LOADED WITH ASA (ACETYLSALICYLIC ACID), "NO LYTICS DUE TO FEAR OF BRAINSTEM HEMORRHAGE," THREE ATTEMPTS WERE MADE WITH A MERCI RETRIEVAL DEVICE BEFORE ATTEMPTING TO STENT. AFTER A GUIDEWIRE SUCCESSFULLY CROSSED THE LESION, A 4X20MM STENT (SUBJECT DEVICE) WAS "PLACED OFF-LABEL WITH PROXIMAL STENT MALAPPOSITION." AN ATTEMPT WAS MADE TO PLACE A 2ND STENT, BUT THE 2ND STENT CATHETER GOT STUCK UPON ITSELF WHEN RETRIEVING THE 2ND STENT SYSTEM. DURING THE RETRIEVAL, "EVERYTHING MOVED' INCLUDING THE BRAIN." THE "PHYSICIAN PULLED THE GUIDEWIRE BACK INTO THE CATHETER AND SAW THE SYSTEM 'RELAX'. THE CATHETER CAME OUT BUT ACCESS TO THE LESION WAS LOST. THE PHYSICIAN "SAW NARROWING AT THE TOP OF THE STENT." A 2.5X9MM BALLOON CATHETER WAS PREPPED, AND ANOTHER ATTEMPT WAS MADE TO PLACE THE 2ND STENT. THE PHYSICIAN "SAW THAT THE STENT WAS COMPLETED OCCLUDED AND ADMINISTERED 4MG OF REOPRO. MULTIPLE ATTEMPT WERE MADE TO CROSS THE STENT BUT THE PROCEDURE WAS STOPPED. PT EXPERIENCED EVOLVING PONTINE AND CEREBELLAR INFARCTS AND THEN BECAME COMATOSE". THE PHYSICIAN STATES: "DID NOT AGGRESSIVELY PRELOAD WITH IIB/IIIA. SHOULD HAVE WAITED FOR FIRST STENT TO EXPAND MORE; DISTAL TINES DID NOT FULLY OPEN WHICH PREVENTED NOSECONE OF SECOND WINGSPAN STENT FROM CROSSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT DELIVERY SYSTEM NJE- STENT, INTRACRANIAL NEUROVASCULAR NJE NEURVOCASULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death 6F ENVOY CATHETER| THERAPY DATE UNK: MERCI RETRIEVAL DEVICE (NON-BSC)| TRANSEND GUIDEWIRE| WINGSPAN STENT (BSC DEVICES)| BALLOON CATHETER (UNK MFG).