BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 25260673 · Received May 22, 2026

    Report

    Report Number
    2029214-2026-00953
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 20, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000277253
    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

    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 OF PIPELINE FAILURE TO OPEN AND PHENOM 27 MICROCATHETER KINK. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, RIGHT INTERNAL CAROTID ARTERY (ICA), OPHTHALMIC SEGMENT ANEURYSM, POINTING DOWNWARD. IT HAD A WITH A MAX DIAMETER OF 4 MM AND A 1 MM NECK DIAMETER. THE LANDING ZONE WAS 3.8 MM DISTALLY AND 4.9 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 10 MM. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED AN OPHTHALMIC SEGMENT ANEURYSM IT WAS REPORTED THAT ON (B)(6) 2026, AT THE DEPARTMENT OF NEUROSURGERY OF (B)(6), THE PHYSICIAN TREATED A RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT ANEURYSM. A MICROCATHETER (FG15150-0615-1S, LOT NUMBER 232175575) WAS ADVANCED TO THE MIDDLE CEREBRAL ARTERY M2 SEGMENT. THEN THE FLOW-DIVERTING STENT (PED-500-18, LOT NUMBER D061249) WAS HYDRATED AND DELIVERED THROUGH THE MICROCATHETER TO THE STRAIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. AT THE STRAIGHT M1 SEGMENT, THE MICROCATHETER WAS WITHDRAWN TO ATTEMPT TO OPEN THE STENT AND THEN PULL IT BACK TO THE INTENDED ANCHORING POINT, BUT THE STENT TIP END FAILED TO OPEN IN THE STRAIGHT SEGMENT. IT WAS THEN PULLED BACK AS A WHOLE TO THE INTERNAL CAROTID ARTERY TO ATTEMPT OPENING AGAIN. TECHNIQUES INCLUDING INCREASING TENSION, RETRIEVING THE MICROCATHETER AND REDEPLOYING, AND PUSHING THE STENT DELIVERY WIRE WERE ATTEMPTED, BUT THE TIP END STILL FAILED TO OPEN. THE SYSTEM HAD TO BE COMPLETELY REMOVED FROM THE BODY. THE MICROCATHETER TIP END WAS KINKED AT THE DISTAL SECTION. A NEW MICROCATHETER (FG15150-0615-1S, LOT NUMBER 232205288) WAS THEN ADVANCED TO THE M2 POSITION, AND A NEW FLOW-DIVERTING STENT (PED-475-20, LOT NUMBER D042360) WAS DELIVERED. THE STENT TIP END OPENED SUCCESSFULLY AND WAS PULLED BACK TO THE INTENDED ANCHORING POINT AND DEPLOYED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SMOOTHLY, THE PATIENT WAS IN GOOD CONDITION, AND THE PREVIOUS STENT AND MICROCATHETER WERE REPORTED AS A COMPLAINT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS FAILURE TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE PIPELINE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS NOT POSITIONED IN A BEND AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER, AND FROM THE PATIENT. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587815 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-500-18 D061249 00763000277253

    Patients

    Seq Age Sex Outcome Treatment
    1