BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 25021973 · Received April 28, 2026

    Report

    Report Number
    2029214-2026-00765
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 28, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000276539
    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 FUSIFORM, UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY INTRACRANIAL ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 6 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 12MM DIAMETER. THE LANDING ZONE WAS 2.5MM DISTALLY AND 3.0 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 DURING ADVANCEMENT OVER THE MARKSMAN MICROCATHETER, THE OPERATOR REPORTED PERSISTENT RESISTANCE. THE DECISION WAS THEN MADE TO IMPLANT A PED-300-18 STENT. AFTER THE STENT ENTERED THE MICROCATHETER, RESISTANCE INCREASED AT THE CATHETER HUB SECTION AND THE ASSISTANT WAS UNABLE TO ADVANCE IT. AFTER FORCEFUL ADVANCEMENT, IT WAS NOTED THAT THE INTRODUCER SHEATH HAD RETRACTED, AND THE STENT WAS UNINTENTIONALLY DEPLOYED IN THE Y-VALVE, BUT IT WAS UNKNOW IF THE STENT BECOME STUCK . SUBSEQUENT INSPECTION REVEALED KINK AND WATER LEAKAGE OF THE MARKSMAN MICROCATHETER PROXIMAL SECTION, WITH THE STENT PUSH ROD STUCK AT THE KINKED SECTION OF THE MICROCATHETER. THE STENT PUSHWIRE WAS NOT DAMAGED. THE MICROCATHETER WAS THEN REPLACED, AND A PED 275-18 STENT WAS IMPLANTED INSTEAD. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS UNKNOWN IF THE PIPELINE USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-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 A 6F-115-NAVIEN GUIDE CATHETER ADDITIONAL INFORMATION WAS RECEIVED. DURING ADVANCEMENT OF THE MARKSMAN MICROCATHETER WITH A GUIDEWIRE TO A HIGHER POSITION, THE OPERATOR REPORTED PERSISTENT RESISTANCE. IT WAS REPORTED THAT THE INTRODUCER SHEATH RETRACTED, WHICH REFERRED TO RETRACTION OF THE STENT DELIVERY SYSTEM INTRODUCER SHEATH AND WAS CONSIDERED A MALFUNCTION. RESISTANCE BETWEEN THE STENT AND THE MARKSMAN MICROCATHETER WAS IDENTIFIED AND ATTRIBUTED TO KINKING OF THE MARKSMAN MICROCATHETER. THE PREMATURE DEPLOYMENT WAS ATTRIBUTED TO THE MICROCATHETER BECOMING KINKED, RESULTING IN HIGH RESISTANCE DURING STENT ADVANCEMENT, WHICH CAUSED RETRACTION OF THE INTRODUCER SHEATH AND PREMATURE STENT DETACHMENT. THE CAUSES OR CONTRIBUTING FACTORS FOR THE MARKSMAN MICROCATHETER KINK AND LEAK ARE UNKNOWN. THE ISSUE THAT RESULTED IN THE DAMAGE FOUND WAS IDENTIFIED AS MICROCATHETER KINKING. NO DAMAGE TO THE PIPELINE PUSHWIRE WAS OBSERVED. THE PREMATURE DEPLOYMENT OCCURRED AFTER THE DEVICE ENTERED THE MICROCATHETER, AND THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANY TIME DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231303 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-300-18 D065052 00763000276539

    Patients

    Seq Age Sex Outcome Treatment
    1