BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 12899459 · Received November 30, 2021

    Report

    Report Number
    2029214-2021-01538
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 30, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000284558
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT 3 PIPELINES FAILED TO OPEN.  THE PATIENT WAS UNDERGOING SURGERY FOR AN "ANEURYSM TREATED WITH FRED." IT WAS A RUPTURED ANEURYSM WITHIN THE LEFT INTERNAL CAROTID ARTERY, IN A BLISTER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.  IT WAS REPORTED THAT THEY COULD NOT GET THE DISTAL END OF ALL DEVICES OPENED, TRIED THREE DIFFERENT DEVICES. THE DEVICES WERE NOT PLACED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WERE RESHEATHED "LESS THAN OR EQUAL TO 2 TIMES." THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINES. THE PIPELINES WERE USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL), IN A RUPTURED BLISTER. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE DEVICES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789275 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-450-25 B217681 00763000284558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown