BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 25218755 · Received May 19, 2026

    Report

    Report Number
    2029214-2026-00911
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 17, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000284374
    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 A PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FLOW DIVERTER STENT IMPLANTATION SACCULAR, UNRUPTURED ANEURYSM LOCATED ON THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 9.3MM AND A 6.9MM NECK DIAMETER. THE LANDING ZONE WAS 3.9MM DISTALLY AND 4.2MM PROXIMALLY. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 7.1MM VESSEL DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AND THE PRU LEVEL WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SIGNIFICANT CONTRAST AGENT RETENTION. IT WAS REPORTED THAT THE SURGEON ESTABLISHED VASCULAR ACCESS AND ADVANCED THE PED2-400-25 STENT TO THE M1 SEGMENT AND DEPLOYED THE TIP. AFTER THE STENT WAS OPENED, IT WAS PULLED BACK TO THE ANCHORING POINT FOR POSITIONING. THE SURGEON CONTINUED TO DEPLOY THE STENT, WHICH OPENED WELL AT THE CLINOID SEGMENT. DEPLOYMENT WAS THEN CONTINUED; HOWEVER, AT THE BEND OF THE CAVERNOUS SINUS, FLATTENING OF THE STENT WAS OBSERVED. THE SURGEON CONTINUED TO DEPLOY APPROXIMATELY 4 MM OF THE STENT TO REDUCE TENSION, FOLLOWED BY REPEATED EXPANSION AND GENTLE BACK-AND-FORTH MOVEMENTS. THE STENT STILL FAILED TO FULLY OPEN. SUBSEQUENTLY, THE SURGEON ADVANCED THE INTERMEDIATE CATHETER AND DEPLOYED AN ADDITIONAL 2 MM OF THE STENT, REPEATEDLY PERFORMING PUSH-AND-PULL MANEUVERS IN AN ATTEMPT TO OPEN THE STENT. AFTER MULTIPLE ATTEMPTS, THE ISSUE REMAINED UNRESOLVED. IT WAS THEN WITHDRAWN FROM THE BODY, AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT WAS NOT APPROVED OFF LABEL. THE CATHETER WAS FLUSHED AND ALL DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308427 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-400-25 B793191 00763000284374

    Patients

    Seq Age Sex Outcome Treatment
    1