BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FG GATEWAY OTW OUS 2.00MM X 15MM

    MDR report key: 3103027 · Received May 9, 2013

    Report

    Report Number
    3008853977-2013-00145
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    July 24, 2009
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MINN
    Product Code
    GBA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. VESSEL DISSECTION IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY AND STENT PLACEMENT TO TREAT LEFT M1 MIDDLE CEREBRAL ARTERY (MCA) TWO STENOTIC LESIONS. POST PROCEDURE, THE PATIENT DID NOT HAVE ANY ADVERSE EVENTS AND HAD A MODIFIED RANKIN SCALE OF 0 AT DISCHARGE. SUBSEQUENT REVIEW OF IMAGING SHOWED THAT AFTER ANGIOPLASTY BUT PRIOR THE STENT PLACEMENT A VESSEL DISSECTION OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY AND STENT PLACEMENT TO TREAT LEFT M1 MIDDLE CEREBRAL ARTERY (MCA) TWO STENOTIC LESIONS. POST PROCEDURE, THE PATIENT DID NOT HAVE ANY ADVERSE EVENTS AND HAD A MODIFIED RANKIN SCALE OF 0 AT DISCHARGE. SUBSEQUENT REVIEW OF IMAGING SHOWED THAT AFTER ANGIOPLASTY BUT PRIOR THE STENT PLACEMENT A VESSEL DISSECTION OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203618 FG GATEWAY OTW OUS 2.00MM X 15MM CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MINN 11980473

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other