BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 10021896 · Received May 4, 2020

    Report

    Report Number
    2029214-2020-00427
    Event Type
    Injury
    Date Received
    May 4, 2020
    Report Date
    May 4, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    WANG Z, TIAN Z, LI W, ET AL. VARIATION OF MASS EFFECT AFTER USING A FLOW DIVERTER WITH ADJUNCTIVE COIL EMBOLIZATION FOR SYMPTOMATIC UNRUPTURED LARGE AND GIANT INTRACRANIAL ANEURYSMS. FRONTIERS IN NEUROLOGY. 2019;10:1. MEDTRONIC RECEIVED A REPORT THROUGH LITERATURE REGARDING PATIENT'S IMPLANTED WITH A PIPELINE DEVICE. IT WAS ALLEGED THAT 12 OF THE 22 PATIENTS INVOLVED IN THE STUDY SHOWED IMPROVEMENT. OF THESE 12 PATIENTS, 6 WERE FULLY RECOVERED, AND 6 SHOWED IMPROVEMENT BUT DID NOT REACH THEIR PREMORBID LEVEL. FOUR PATIENTS SHOWED WORSENING COMPARED WITH THEIR PREOPERATIVE STATUS, INCLUDING TWO WITH ISCHEMIC COMPLICATIONS. ALL FOUR OF THESE PATIENTS PRESENTED WITH MORE SEVERE COMPRESSIONAL SYMPTOMS THAN THEIR PREOPERATIVE STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486313 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other