BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 25137622 · Received May 11, 2026

    Report

    Report Number
    2029214-2026-00848
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000255169
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187041 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-500-25 D078411 00763000255169

    Patients

    Seq Age Sex Outcome Treatment
    1