BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 24982534 · Received April 24, 2026

    Report

    Report Number
    2029214-2026-00732
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 24, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000284350
    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: PRODUCT ID PED2-400-16 (D063759); PRODUCT TYPE: IMPLANT DATE; EXPLANT DATE PRODUCT ID FG15150-0615-1S (231914451); PRODUCT TYPE: IMPLANT DATE N/A; EXPLANT DATE N/A. 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 PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT CLINOID C5 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.3 MM AND A 3.0 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 7.8MM DIAMETER. THE LANDING ZONE WAS 3.1MM DISTALLY AND 4.0MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT AFTER THE OPERATOR ESTABLISHED ACCESS, A PHENOM 27 MICROCATHETER WAS POSITIONED IN PLACE. A SHIELD PED400-18 DEVICE WAS UNPACKED AND HYDRATED. THE DISTAL END OF THE DEVICE WAS ADVANCED THROUGH THE Y-VALVE TO THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. WHILE THE ASSISTANT ADVANCED THE DELIVERY WIRE TO ITS FULL EXTENT, VERY LITTLE RESISTANCE WAS NOTED. THE DISTAL END OF THE DEVICE WAS UNABLE TO ENTER THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. THE OPERATOR THEN WITHDREW THE ENTIRE DEVICE ONTO THE TABLE AND ATTEMPTED TO ADVANCE THE DELIVERY WIRE BACK AND FORTH; HOWEVER, THE STENT REMAINED STATIONARY. IT WAS SUBSEQUENTLY NOTED THAT THE DEVICE HAD BECOME DETACHED (DEVICE DETACHMENT). THE OPERATOR THEN REPLACED THE DEVICE WITH A PED400-16 PIPELINE FLOW DIVERTER STENT. AFTER HYDRATION, THE DEVICE WAS ADVANCED TO THE C7 SEGMENT. IN SITU DEPLOYMENT WAS ATTEMPTED. DEPLOYMENT WAS INITIATED IN THE INTERNAL CAROTID ARTERY BY DEPLOYING THE DISTAL END. THE OPERATOR SLOWLY RETRACTED THE DELIVERY CATHETER TO EXPOSE THE RADIOPAQUE MARKERS. SUBSEQUENTLY, THE DELIVERY WIRE STABILIZED WHILE THE DELIVERY CATHETER WAS WITHDRAWN TO DEPLOY THE DISTAL END. HOWEVER, THE DISTAL END FAILED TO OPEN. AT THAT TIME, APPROXIMATELY 6 MM OF THE DEVICE HAD ALREADY BEEN DEPLOYED. THE OPERATOR THEN INCREASED TENSION AND ADVANCED THE DELIVERY WIRE WHILE FIXING THE PHENOM 27 MICROCATHETER IN AN ATTEMPT TO PROMOTE EXPANSION, AND AN ADDITIONAL 4 MM OF THE DISTAL END WAS DEPLOYED; HOWEVER, THE DEVICE STILL FAILED TO OPEN. THE OPERATOR ATTEMPTED TO RECAPTURE THE DEVICE AND REDEPLOY THE DISTAL END. DURING THIS PROCESS, THE SYSTEM MIGRATED DOWNWARD, AND THE OPERATOR DID NOT REDUCE TENSION. DEPLOYMENT OF THE DISTAL END WAS CHANGED TO A TENSION-INCREASING TECHNIQUE. APPROXIMATELY 10 MM OF THE DISTAL END WAS DEPLOYED, SHOWING A FUSIFORM CONFIGURATION WITH POOR OPENING. DESPITE REPEATED ADJUSTMENTS WITH INCREASING AND DECREASING TENSION TO PROMOTE EXPANSION, THE ISSUE COULD NOT BE RESOLVED. FOR PROCEDURAL SAFETY, THE ENTIRE SYSTEM WAS WITHDRAWN FROM THE BODY. THE DEVICE COULD NOT BE REMOVED FROM THE PHENOM 27 MICROCATHETER. A NEW DEVICE AND A NEW PHENOM 27 MICROCATHETER WERE THEN USED, AND THE PROCEDURE WAS ULTIMATELY COMPLETED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE AN INTERMEDIATE CATHETER ¿(B)(6), STRYKER GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137326 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-400-18 D046737 00763000284350

    Patients

    Seq Age Sex Outcome Treatment
    1