BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 25045501 · Received April 30, 2026

    Report

    Report Number
    2029214-2026-00778
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 28, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000449544
    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

    H6: CODING WAS UPDATED UPON REVIEW. 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.

    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 DISTAL END OF THE PIPELINE STENT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR FLOW-DIVERTING STENT TREATMENT OF AN AMORPHOUS, UNRUPTURED, OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 7.2 MM AND A 4.3 MM NECK DIAMETER. THE LANDING ZONE WAS 3.8 MM DISTALLY AND 5.0 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. 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 FLOW-DIVERTING STENT TREATMENT FOR AN ANEURYSM WAS PERFORMED. THE MICROCATHETER WAS POSITIONED APPROPRIATELY, AND THE STENT WAS DELIVERED. AFTER REACHING THE TARGET LOCATION, DEPLOYMENT WAS INITIATED IN THE MIDDLE CEREBRAL ARTERY. THE DISTAL END EXHIBITED A ¿FISH-MOUTH¿ CONFIGURATION. AFTER APPROXIMATELY 10 MM OF DEPLOYMENT, THE STENT REMAINED UNOPENED. THE STENT WAS RESHEATHED THREE TIMES, AND REPEATED DEPLOYMENT ATTEMPTS WERE UNSUCCESSFUL. THE STENT WAS THEN WITHDRAWN TO THE INTERNAL CAROTID ARTERY FOR REDEPLOYMENT, AND APPROXIMATELY 15 MM WAS DEPLOYED. THE MID-SEGMENT OPENED, WHILE THE DISTAL END CONTINUED TO EXHIBIT A ¿FISH-MOUTH¿ APPEARANCE. DESPITE MANEUVERS INCLUDING DEVICE MANIPULATION AND ELONGATION, THE DISTAL END DID NOT OPEN. THE STENT WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. 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). ANCILLARY DEVICES INCLUDE A 6F NAVIEN GUIDE CATHETER AND A STRYKER XT27 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60101 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-500-16 D074632 00763000449544

    Patients

    Seq Age Sex Outcome Treatment
    1