BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 25125044 · Received May 8, 2026

    Report

    Report Number
    2029214-2026-00844
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 8, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000276638
    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 THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED, SMALL, RIGHT OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5.2 MM AND A 3.8 MM NECK DIAMETER. THE LANDING ZONE WAS 2.8 MM DISTALLY AND 3.2 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AT AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT AFTER THE FA-55150-1030 MICROCATHETER (LOT NO.: 229150226) WAS POSITIONED, DELIVERY OF THE PED-325-20 STENT (LOT NO.: B732281) WAS INITIATED. AFTER THE STENT WAS ADVANCED AND PARTIALLY DEPLOYED IN THE M1 SEGMENT, IT DID NOT OPEN PROPERLY. THE DEVICE WAS WITHDRAWN AND INSPECTED OUTSIDE THE BODY, WHERE TWISTING AND DEFORMATION WERE OBSERVED APPROXIMATELY 5 MM FROM THE DISTAL TIP END OF THE STENT. THE STENT COULD NOT BE OPENED EVEN OUTSIDE THE BODY. THEREFORE, A NEW STENT (PED-350-18, LOT NO.: D060984) WAS USED AS A REPLACEMENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SMOOTH ADVANCEMENT AND DEPLOYMENT. 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. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A 8F GUIDING CATHETER, A MARKSMAN MICROCATHETER, A SYNTHRO GUIDEWIRE, AND A NAVIEN 6F-115 INTERMEDIATE CAT HETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464915 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-325-20 B732281 00763000276638

    Patients

    Seq Age Sex Outcome Treatment
    1