BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1131724 · Received August 21, 2008

    Report

    Report Number
    2939204-2008-00335
    Event Type
    Death
    Date Received
    August 21, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 28, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE: FOR NO ALLEGATION OF DEVICE MALFUNCTION OR NON CONFORMANCE. DEVICE EVALUATION: CONCLUSIONS: FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THIS BATCH MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. BASED ON THE INFO PROVIDED, THERE IS NO INDICATION THAT THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE LABELING AND THIS DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. A REVIEW OF THE LABELING CONFIRMED THAT IT CONTAINS LANGUAGE REGARDING THE POTENTIAL PROCEDURAL COMPLICATION OF THROMBUS. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION OR NON COMPLIANCE AND FROM THE INFO AVAILABLE IT CAN BE CONCLUDED THAT THE DEVICE WAS USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE SO A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED EIGHT DAYS PRIOR TO THE PROCEDURE WITH A BILATERAL CEREBELLAR INFARCT FROM DIFFUSE VERTEBRAL/BASILAR DISEASE AND BILATERAL DEEP VEIN THROMBOSIS (DVT). THE PT WAS INITIALLY GIVEN MEDICAL THERAPY TO TREAT THESE CONDITIONS. ANGIOGRAPHY REVEALED 70% STENOSIS IN THE RIGHT VERTEBRAL ARTERY, JUST PROXIMAL TO THE VERTEBRAL/BASILAR JUNCTION, AND 40% STENOSIS IN THE RIGHT BASILAR ARTERY. ANGIOPLASTY WAS PERFORMED IN THE RIGHT VERTEBRAL AND BASILAR ARTERIES AND AN ANGIOGRAM DEMONSTRATED "EXCELLENT RESOLUTION OF THE STENOSIS". TWO STENTS [INCLUDING SUBJECT DEVICE] WERE PLACED IN THE RIGHT VERTEBRAL/BASILAR SYSTEM WITHOUT ISSUE. THE PROCEDURE OUTCOME WAS SIGNIFICANT IMPROVEMENT IN THE POSTERIOR CIRCULATION FLOW AND TRANSIT TIME. ONE HOUR POST PROCEDURE, THE PT WAS RESUSCITATED FOLLOWING RESPIRATORY ARREST AND SUFFERED HYPOPERFUSION TO THE BRAIN SECONDARY TO HYPOTENSION, PT WAS PLACED ON NEOSYNEPHRINE AND DOBUTAMINE FOR PRESSOR SUPPORT. THE FOLLOWING DAY, THE PT'S NEUROLOGICAL STATUS CHANGED AND AN EMERGENCY ARTERIOGRAM REVEALED COMPLETE OCCLUSION OF THE RIGHT VERTEBRAL ARTERY DUE TO A THROMBUS IN THE STENTED REGION. THE PHYSICIAN RELATED THE CAUSE OF THE THROMBUS TO THE HYPOTENSION AND HYPOPERFUSION, DESPITE THE ANTI THROMBOTIC REGIMEN. THE PHYSICIAN RESOLVED THE THROMBUS WITH ANGIOPLASTY USING TWO DILATION CATHETERS, 3000U OF HEPARIN AND 12MG OF REOPRO. THE PT WAS PLACED ON INTRA VENOUS REOPRO. TWO DAYS LATER, THE PATIENT DEMONSTRATED HEMIPARESIS AND ONLY RESPONDED TO SOME COMMAND. A CT SCAN REVEALED NEW CEREBELLAR INFARCTS, LOSS OF THE FOURTH VENTRICLE AND BRAIN STEM COMPRESSION. THE PT WAS TAKEN TO SURGERY FOR AN EMERGENCY POSTERIOR FOSSA DECOMPRESSION. THE FOLLOWING DAY, THE PT'S MENTAL CONDITION WAS NOTED TO FURTHER DETERIORATE AND A CT SCAN WAS ORDERED. AS THE PT WAS BEING POSITIONED FOR THE SCAN, HE SUFFERED A SEVERE BRADYCARDIA THAT WAS TREATED WITH ATROPINE AND LEVOPHED WAS ADMINISTERED FOR PRESSOR SUPPORT AND THE INITIAL MEDICATION STOPPED. A CT SCAN REVEALED A NEW PONTINE INFARCT, CONTINUED LOSS OF THE FOURTH VENTRICLE, AND PERSISTENT BRAIN STEM COMPRESSION. THE FAMILY DECIDED TO WITHDRAW CARE AND THE PT EXPIRED NINETY MINUTES LATER. IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM (NJE) NEUROVASCULAR STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. WS030015 0009559161

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| O| R 5000U OF HEPARIN| BOSTON SCIENTIFIC WINGSPAN STENT| SYNCHRO GUIDEWIRE| THREE GATEWAY DILATION CATHETERS