BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 25259810 · Received May 22, 2026

    Report

    Report Number
    2029214-2026-00949
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000449469
    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: PHENOM 27 MICROCATHETER PRODUCT ID FG15150-0615-1S (LOT: 232325757);  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 FLEX WITH SHIELD TECHNOLOGY STENT FAILED TO OPEN AT THE DISTAL END AND WAS OBSERVED TO HAVE ABNORMAL MORPHOLOGY AND DAMAGE. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANEURYSM AT THE OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4.8 MM AND A 2.6 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.3 MM DISTALLY AND 4.73 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 7 MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS IN NORMAL RANGE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS REPORTED AS NORMAL A 6F 90 CM LONG SHEATH WAS ADVANCED SMOOTHLY TO THE C2 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY UNDER THE GUIDANCE OF A 0.035-INCH LOACH GUIDEWIRE AND A MULTIFUNCTIONAL ANGIOGRAPHIC CATHETER MPA. A TON-BRIDGE SILVER SNAKE 6F 115 CM INTERMEDIATE CATHETER WAS ADVANCED TO THE POSTERIOR BEND OF THE CAVERNOUS SEGMENT USING A COAXIAL TECHNIQUE. THE PHENOM27 MICROCATHETER WAS ADVANCED TO THE IPSILATERAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY UNDER THE GUIDANCE OF A DC WIRE. BASED ON THE MEASURED VALUES, THE PED2-475-18 MODEL WAS SELECTED. THE DEVICE WAS FULLY HYDRATED WITH HIGH-PRESSURE SALINE AND THEN SMOOTHLY DELIVERED TO THE MIDDLE CEREBRAL ARTERY AFTER HYDRATION. THE PUSHER GUIDEWIRE WAS STABILIZED AND THE PHENOM27 MICROCATHETER WAS WITHDRAWN TO EXPOSE THE TIP END OF THE STENT; HOWEVER, THE TIP END FAILED TO OPEN. A LONGER SEGMENT WAS DEPLOYED, BUT THE TIP END STILL COULD NOT BE OPENED. GENTLE PUSH-PULL AND OSCILLATION SLIGHTLY IMPROVED THE MID-SEGMENT, BUT THE TIP END STILL COULD NOT BE OPENED. RESHEATHING AND REDEPLOYMENT WERE ATTEMPT ED, BUT THE TIP END STILL FAILED TO OPEN. FURTHER PUSH-PULL AND OSCILLATION WERE ATTEMPTED IN HOPES OF IMPROVING OPENING OF THE TIP END, BUT IT STILL DID NOT OPEN. UNDER FLUOROSCOPY, ABNORMAL MORPHOLOGY OF THE TIP END WAS OBSERVED (INCONSISTENT WITH THE USUAL MORPHOLOGY OF THE PED TIP END). THEREFORE, THE PED2-475-18 WAS RESHEATHED INTO THE PHENOM27 AND THEY WERE REMOVED TOGETHER FROM THE BODY, AND DAMAGE TO THE STENT WAS OBSERVED. A NEW PHENOM27 WAS UNPACKED, AND A PED2-450-20 WAS SELECTED. THE ABOVE STEPS WERE REPEATED. THIS TIME, THE TIP END OF THE STENT OPENED SMOOTHLY, AND THE MID-SEGMENT AND DISTAL SEGMENT ALSO DEPLOYED RELATIVELY SMOOTHLY. THE OVERALL PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE PIPELINE WAS NOT POSITIONED IN A BEND, HAD BEEN DEPLOYED LESS THAN 50% WHEN IT FAILED TO OPEN, AND WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE WERE REPORTED AS RELEASING A LONGER SEGMENT, SLIGHT OSCILLATION, RESHEATHING AND REDEPLOYMENT. ANCILLARY DEVICES INCLUDED 6F 90 CM LONG SHEATH, 6F 115 CM TON-BRIDGE SILVER SNAKE INTERMEDIATE CATHETER, PHENOM 27 MICROCATHETER, 0.035-INCH LOACH GUIDEWIRE, ACHIEVA MEDICAL DC WIRE, 0.014 INCH, 200 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267684 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-475-18 D060517 00763000449469

    Patients

    Seq Age Sex Outcome Treatment
    1