BEUDAMED
    FDA Adverse Event Death Summary report: N

    FG GATEWAY OTW OUS 2.00MM X 15MM

    MDR report key: 3601524 · Received January 31, 2014

    Report

    Report Number
    3008853977-2014-00034
    Event Type
    Death
    Date Received
    January 31, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MINN
    Product Code
    PAV
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 WAS NOT RETURNED; THEREFORE, ANALYSIS CANNOT BE PERFORMED. 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. PATIENT HEMORRHAGE, STROKE AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISPOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH 72% STENOSIS IN THE RIGHT M1 MIDDLE CEREBRAL ARTERY (MCA). THE SUBJECT DEVICE WAS ADVANCED INTO THE STENOSED LESION AND INFLATED TO 6 ATM. THE DEVICE WAS REMOVED AND THE STENOSIS WAS NOT IMPROVED. THE DEVICE WAS READVANCED AND REINFLATED TO 8 ATM. THE STENOSIS SEEMED TO BE IMPROVED UNDER ANGIOGRAPHY AND THE DEVICE WAS REMOVED. HOWEVER, THE CT-SCAN SHOWED A HEMORRHAGE. THE HEMORRHAGE RESULTED IN A STROKE. THE PATIENT WAS TREATED WITH ASPIRIN, LIPITOR AND LIUSUANQINGLUPIGELEI PIAN. ONE DAY POST PROCEDURE THE PATIENT PASSED AWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH 72% STENOSIS IN THE RIGHT M1 MIDDLE CEREBRAL ARTERY (MCA). THE SUBJECT DEVICE WAS ADVANCED INTO THE STENOSED LESION AND INFLATED TO 6 ATM. THE DEVICE WAS REMOVED AND THE STENOSIS WAS NOT IMPROVED. THE DEVICE WAS READVANCED AND REINFLATED TO 8 ATM. THE STENOSIS SEEMED TO BE IMPROVED UNDER ANGIOGRAPHY AND THE DEVICE WAS REMOVED. HOWEVER, THE CT-SCAN SHOWED A HEMORRHAGE. THE HEMORRHAGE RESULTED IN A STROKE. THE PATIENT WAS TREATED WITH ASPIRIN, LIPITOR AND LIUSUANQINGLUPIGELEI PIAN. ONE DAY POST PROCEDURE THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67145 FG GATEWAY OTW OUS 2.00MM X 15MM CATHETER, BALLOON TYPE PAV BOSTON SCIENTIFIC - MINN 16177380

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death EXCELSIOR MICROCATHETER (STRYKER)| SYNCHRO 300 GUIDEWIRE (STRYKER)