BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 12866487 · Received November 23, 2021

    Report

    Report Number
    2029214-2021-01520
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536019782
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    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 THE PIPELINE DISTAL AND PROXIMAL ENDS FAILED TO OPEN. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU AND WAS NOT USED OFF-LABEL. THE MIDDLE SECTION OF THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THERE WERE NO FURTHER STEPS TAKEN TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED WITH THE MICROCATHETER FROM THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS 67. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED STAGNATION IN THE ANEURYSM AND THE PARENT VESSEL OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT CAVERNOUS WITH A MAX DIAMETER OF 11MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE: NEURON MAX SHEATH, PHENOM PLUS GUIDE CATHETER, AND A PHENOM 27 150CM MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763116 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-500-30 A877523 00847536019782

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female