BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 24973190 · Received April 23, 2026

    Report

    Report Number
    2029214-2026-00725
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000277178
    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 THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT INTRACRANIAL C5 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 7 MM NECK DIAMETER. THE LANDING ZONE WAS 3.7 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT AFTER ACCESS WAS ESTABLISHED, THE PED- 475-20 STENT WAS DELIVERED FOR TREATMENT. UPON RETRACTING THE STENT MIC ROCATHETER, THE TIP END DID NOT OPEN PROPERLY, AND UNDER X-RAY THE STENT VISUALIZATION APPEARED ROUGH. AFTER REPEATED RESHEATHING AND REDEPLOYMENT, THE STENT STILL FAILED TO OPEN PROPERLY. IT WAS REMOVED FROM THE BODY, AND DEFORMATION AND ROUGHNESS AT THE TIP END OF THE STENT WERE OBSERVED. SUBSEQUENTLY, THE OPERATOR REPLACED IT WITH A 475-18 STENT, WHICH WAS SUCCESSFULLY OPENED AND DEPLOYED, COMPLETING THE PROCEDURE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN AND WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A 6F-115 ¿ PROWISEN GUIDE CATHETER, PHENOM27 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234322 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-475-20 D041069 00763000277178

    Patients

    Seq Age Sex Outcome Treatment
    1