BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE

    MDR report key: 6436912 · Received March 27, 2017

    Report

    Report Number
    2029214-2017-00226
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    January 9, 2017
    Report Date
    March 3, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ENDOVASCULAR FLOW DIVERSION FOR TREATMENT OF ANTERIOR COMMUNICATING ARTERY REGION CEREBRAL ANEURYSMS: A SINGLE-CENTER COHORT OF 50 CASES. GEOFFREY P COLBY,1 MATTHEW T BENDER,1 LI-MEI LIN,2 NARLIN BEATY ET. AL. THE DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. MDR RELATED TO THIS EVENT: 2029214-2017-00226 2029214-2017-00227. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH THE LITERATURE REVIEW THAT THE PIPELINE DEVICE DID NOT OPEN. IT WAS REPORTED THAT ONE CASE WAS ABORTED DUE TO THE PIPELINE NOT OPENING WHILE USING THE GUIDE CATHETER AND MICROCATHETER COMBINATION. IT WAS REPORTED THAT THERE WAS SIGNIFICANT PROXIMAL VESSEL TORTUOSITY. THIS CASE WAS SUCCESSFULLY COMPLETED AT LATER TIME. SINGLE CENTER STUDY OF 50 CASES. THE AVERAGE AGE WAS 56 YEARS AND 46% OF THE PATIENTS WERE FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219299 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA NV UNK PIPELINE NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1