BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 4394861 · Received January 7, 2015

    Report

    Report Number
    3008853977-2015-00005
    Event Type
    Death
    Date Received
    January 7, 2015
    Date of Event
    November 1, 2009
    Report Date
    December 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED. BECAUSE THE REPORTED EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITH THE DIRECTIONS FOR USE AND/OR DEVICE LABELING, A CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. THE TREATMENT DATE FOR THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ARTICLE THAT THE PATIENT NEVER FULLY REGAINED CONSCIOUSNESS FOLLOWING A COIL EMBOLIZATION PROCEDURE. TWO DAYS POST PROCEDURE, IMAGING SHOWED AREAS OF ACUTE INFARCT INVOLVING MULTIPLE BILATERAL VASCULAR TERRITORIES WITHIN THE CEREBRAL HEMISPHERES, CEREBELLUM AND PONS. THE PATIENT HAD HEMIPARESIS AND DIED. THE EXACT CAUSE OF DEATH WAS NOT REPORTED; HOWEVER, THE BRAIN AT AUTOPSY SHOWED INNUMERABLE (DIFFUSE) INTRAVASCULAR AGGREGATES OF AMORPHOUS FOREIGN MATERIAL, WHICH WAS NON-REFRACTILE, NON-POLARIZABLE, GRANULAR, AND PREDOMINANTLY BASOPHILIC. RARE VESSELS WITHIN THE PONS AND CEREBELLUM ALSO CONTAINED LAMELLATED EOSINOPHILIC FOREIGN MATERIAL. VASCULAR STENOSIS AND OBLITERATION WERE ASSOCIATED WITH DISCRETE ZONAL AREAS OF INFARCT AND NEOINTIMAL PROLIFERATION. APPROXIMATELY 100 ARTERIES WERE AFFECTED IN 40 TISSUE SECTIONS OF THE BRAIN SAMPLED AT AUTOPSY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ARTICLE THAT THE PATIENT NEVER FULLY REGAINED CONSCIOUSNESS FOLLOWING A COIL EMBOLIZATION PROCEDURE. TWO DAYS POST PROCEDURE, IMAGING SHOWED AREAS OF ACUTE INFARCT INVOLVING MULTIPLE BILATERAL VASCULAR TERRITORIES WITHIN THE CEREBRAL HEMISPHERES, CEREBELLUM AND PONS. THE PATIENT HAD HEMIPARESIS AND DIED. THE EXACT CAUSE OF DEATH WAS NOT REPORTED; HOWEVER, THE BRAIN AT AUTOPSY SHOWED INNUMERABLE (DIFFUSE) INTRAVASCULAR AGGREGATES OF AMORPHOUS FOREIGN MATERIAL, WHICH WAS NON-REFRACTILE, NON-POLARIZABLE, GRANULAR, AND PREDOMINANTLY BASOPHILIC. RARE VESSELS WITHIN THE PONS AND CEREBELLUM ALSO CONTAINED LAMELLATED EOSINOPHILIC FOREIGN MATERIAL. VASCULAR STENOSIS AND OBLITERATION WERE ASSOCIATED WITH DISCRETE ZONAL AREAS OF INFARCT AND NEOINTIMAL PROLIFERATION. APPROXIMATELY 100 ARTERIES WERE AFFECTED IN 40 TISSUE SECTIONS OF THE BRAIN SAMPLED AT AUTOPSY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13884 UNKNOWN_NEUROVASCULAR_PRODUCT DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC CORK, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| O ECHELON 10 MICROCATHETER (NON-STRYKER)| SIMMONS 2 CATHETER (NON-STRYKER)| FASDASHER 14 GUIDEWIRE (BOSTON SCIENTIFIC)| 038 GLIDEWIRE (NON-STRYKER)| 5FR VTK CATHETER (NON-STRYKER)| GDC COILS (BOSTON SCIENTIFIC) - UNKNOWN QUANTITY| 035 COOK BENTSON GUIDEWIRE (NON-STRYKER)| 6FR 80CM SHUTTLE SHEATH (NON-STRYKER)