BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 9212650 · Received October 20, 2019

    Report

    Report Number
    2029214-2019-01041
    Event Type
    Death
    Date Received
    October 20, 2019
    Date of Event
    December 1, 2014
    Report Date
    October 20, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CHIN J CEREBROVASC DIS,JAN. 18, 2018,VOL. 15,NO. 1. MEDIUM AND LONG-TERM EFFECTS OF PIPELINE EMBOLIZATION DEVICE FOR THE TREATMENT OF LARGE AND GIANT INTRACRANIAL ANTERIOR CIRCULATION. ANEURYSMS. GAI YANTING,PENG FANGQIANG, TAN SHUBIN, LI YANJIANG, LIU MINDI, WANG WEI, JIAN XINGE, SONG DONGLEI. DONGLEI BRAIN DOCTOR GROUP, SHANGHAI,CHINA MEDTRONIC RECEIVED A REPORT FROM A LITERATURE ARTICLE REGARDING THE MEDIUM AND LONG TERM EFFECTS AND SAFETY OF PIPELINE EMBOLIZATION DEVICE (PED) FOR THE TREATMENT OF LARGE AND GIANT INTRACRANIAL ANTERIOR CIRCULATION ANEURYSMS. THE STUDY WAS PERFORMED FROM DEC 2014 TO DEC 2016. 36 PATIENTS WERE INVOLVED IN THE STUDY, THE MEAN DIAMETER OF THE ANEURYSMS WAS 16.6MM 8 ANEURYSMS WERE LOCATED IN THE CAROTID CAVERNOUS SINUS SEGMENT, 22 IN THE OPHTHALMIC ARTERY SEGMENT, 5 IN THE INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING SEGMENT, AND 1 IN THE M1 SEGMENT OF MIDDLE CEREBRAL ARTERY. 7 ANEURYSMS WERE TREATED WITH THE PIPELINE, 28 WITH THE PIPELINE AND COIL. AFTER 6 MONTH FOLLOW-UP, 1 ANEURYSM WAS OCCLUDED SUBTOTALLY, 2 WERE NOT CURED. MRI CONFIRMED AFTER OPERATION THAT 10 PATIENTS HAD ASYMPTOMATIC SCATTERED SPOTTED ISCHEMIC FOCI, 4 HAD CEREBRAL PARENCHYMAL HEMORRHAGE, 1 OF THEM DIED, 1 RECOVERED WELL AFTER TREATMENT, AND THE OTHER 2 WERE ASYMPTOMATIC CEREBRAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006575 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE NOT-RPT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death