BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 25033278 · Received April 29, 2026

    Report

    Report Number
    2029214-2026-00768
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000284282
    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 A PIPELINE THAT FAILED TO OPEN IN THE MID-SEGMENT OF THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6MM AND A 6MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 3.5MM DISTAL AND 3.8MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT WAS POST PROCEDURE, "FOLLOWING STENT REPLACEMENT, SIGNIFICANT CONTRAST STAGNATION WAS OBSERVED IN THE ANEURYSM, WITH NO VASCULAR LOSS DETECTED. NO IMAGES ARE AVAILABLE FOR REVIEW. IT WAS REPORTED THAT STENT DELIVERY WAS STARTED, THE PHENOM27 (P27) MICROCATHETER WAS POSITIONED AT THE M1 SEGMENT, AND STENT DELIVERY WAS STARTED. AS THE PATIENT¿S M1 SEGMENT WAS NOT STRAIGHT, THE CUSTOMER DECIDED TO DEPLOY THE STENT IN SITU. THE P27 MICROCATHETER WAS RETRACTED, AND DEPLOYMENT OF THE TIP OF THE STENT WAS INITIATED. THE STENT TIP GRADUALLY OPENED BUT INITIALLY APPEARED SOMEWHAT ROD-SHAPED. WITH ADVANCEMENT OF THE STENT, THE TIP OPENED SUCCESSFULLY. AFTER THE DISTAL END WAS POSITIONED, DEPLOYMENT OF THE MID-SEGMENT OF THE STENT WAS ATTEMPTED. THE STENT WAS ADVANCED, DUE TO ANGULATION AT THE C6¿C7 SEGMENT AND TYPE III CAVERNOUS SINUS TORTUOSITY, THE MID-SEGMENT OF THE STENT REMAINED UNOPENED. REPEATED PUSH-AND-PULL MANEUVERS WERE PERFORMED, WITH DEPLOYMENT MORE DISTANCE, ATTEMPTED APPROXIMATELY 20 MINUTES, BUT THE MID-SEGMENT REMAINED UNOPENED. THE SURGEON THEN DECIDED TO REPLACE THE STENT. IT WAS REPLACED WITH A DIFFERENT MODEL, AND THE P27 WAS ALSO REPLACED, AS THERE WAS CONCERN THAT REPEATED MANIPULATION MIGHT AFFECT THE MICROCATHETER. AFTER REPLACING BOTH THE STENT AND THE MICROCATHETER, THE PROCEDURE PROCEEDED SMOOTHLY, AND THE SURGERY WAS COMPLETED SAFELY. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER C OMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS NOT USED FOR ANY INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE A PRECISION MEDICAL 6F115 GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16625 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-375-25 D053371 00763000284282

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female