BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 24973817 · Received April 23, 2026

    Report

    Report Number
    2029214-2026-00727
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000276713
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: FG15150-0615-1S (LOT: 232045494); IMPLANT DATE N/A; EXPLANT DATE N/A. 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

    MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED MALL ANEURYSM AT THE LEFT OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 4.3 MM AND A 3.2MM NECK DIAMETER. THE LANDING ZONE WAS 3.13MM DISTALLY AND 3.4MM PROXIMALLY.  IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.  THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 5MM DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN.  IT WAS REPORTED THAT AFTER THE OPERATOR POSITIONED THE MICROCATHETER, HYDRATION OF THE STENT (PED-350-18) WAS INITIATED. AFTER COMPLETION OF HIGH-PRESSURE HYDRATION, THE STENT WAS ADVANCED NORMALLY INTO THE MICROCATHETER. WHEN ADVANCED TO THE MID SEGMENT, THE OPERATOR REPORTED SLIGHTLY INCREASED RESISTANCE. AFTER CONTINUED ADVANCEMENT TO THE TARGET POSITION, IT WAS OBSERVED THAT THE STENT RADIOPAQUE MARKER COIL HAD KINKED INSIDE THE MICROCATHETER; UNDER FLUOROSCOPY, THE POSITION OF THE RADIOPAQUE MARKER COIL HAD SHIFTED TO THE DISTAL RESHEATHING POINT AT THE TAIL END OF THE STENT, AND THE STENT COULD NOT BE PUSHED OUT NORMALLY AND THE ENTIRE SYSTEM COULD ONLY BE WITHDRAWN AS A WHOLE. AFTER REMOVAL, WHEN THE STENT WAS PUSHED OUT OUTSIDE THE BODY, THE DISTAL RADIOPAQUE MARKER COIL OF THE STENT WAS FOUND TO BE FRACTURED, AND THE MICROCATHETER WAS ALSO KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED ONLY AFTER REPLACING WITH THE MICROCATHETER  AND THE STENT AND ADVANCING THEM TO THE TARGET POSITION. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN INTERMEDIATE CATHETER 5F NAVIEN 115, LOT NUMBER D077156.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234543 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-350-18 D065160 00763000276713

    Patients

    Seq Age Sex Outcome Treatment
    1