BEUDAMED
    FDA Adverse Event Death Summary report: N

    GATEWAY PTA DILATION CATHETER

    MDR report key: 1131745 · Received August 21, 2008

    Report

    Report Number
    2939204-2008-00337
    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
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF DEVICE MALFUNCTION OR NON CONFORMANCE.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED EIGHT DAYS PRIOR TO THE PROCEDURE WITH A BILATERAL CEREBELLA INFARCT FROM DIFFUSE VERTEBRAL/BASILAR DISEASE AND BILATERAL DEEP VEIN THROMBOSIS (DVT). THE PATIENT 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 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 PATIENT WAS RESUSCITATED FOLLOWING RESPIRATORY ARREST AND SUFFERED HYPOPERFUSION TO THE BRAIN SECONDARY TO HYPOTENSION, PATIENT WAS PLACED ON NEOSYNEPHRINE AND DOBUTAMINE FOR PRESSOR SUPPORT. THE FOLLOWING DAY, THE PATIENT'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 [INCLUDING SUBJECT DEVICE, 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 PATIENT WAS TAKEN TO SURGERY FOR AN EMERGENCY POSTERIOR FOSSA DECOMPRESSION. THE FOLLOWING DAY, THE PATIENT'S MENTAL CONDITION WAS NOTED TO FURTHER DETERIORATE AND A CT SCAN WAS ORDERED. AS THE PATIENT 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 PATIENT EXPIRED NINETY MINUTES LATER. IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY PTA DILATION CATHETER (GBA) DILATATION BALLOON CATHETER GBA NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. 20722-1540 11371740

    Patients

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