BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 24105455 · Received January 17, 2026

    Report

    Report Number
    2029214-2026-00100
    Event Type
    Malfunction
    Date Received
    January 17, 2026
    Date of Event
    October 19, 2025
    Report Date
    January 17, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000277291
    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

    H3: PRODUCT ANALYSIS OF PED-500-35, LOTNO: D052736 AS FOUND CONDITION: THE PIPELINE FLEX DEVICE WAS RETURNED FOR ANALYSIS INSIDE A DISPENSER COIL, INSIDE AN OPEN PIPELINE FLEX INNER POUCH, INSIDE A SEALED BIOHAZARD BAG, AND INSIDE A SHIPPING BOX. THE REPORTED MARKSMAN CATHETER WAS NOT RETURNED WITH THE PIPELINE FLEX DEVICE. DAMAGED LOCATION DETAILS: THE PIPELINE FLEX TIP COIL WAS IN GOOD CONDITION. THE DISTAL AND PROXIMAL DPS RESTRAINTS AND DPS SLEEVES WERE INTACT, WITH NO SIGNS OF DAMAGE. NO DEFECTS WERE FOUND ON THE RE-SHEATHING PAD. THE DISTAL HYPOTUBE WAS IN GOOD CONDITION. THE PUSHER WIRE WAS OBSERVED TO BE DETACHED AT THE PROXIMAL WELD, AND THE REMAINING PROXIMAL SEGMENT WAS NOT RETURNED. THE BRAID WAS ALREADY DETACHED FROM THE PUSHER WIRE WHEN IT WAS RETURNED; THEREFORE, THE DISTAL AND PROXIMAL ENDS COULD NOT BE IDENTIFIED. BOTH BRAID ENDS WERE OPEN AND FRAYED. THE BRAID¿S MIDDLE SECTION WAS FULLY OPEN WITHOUT DAMAGE. NO OTHER ANOMALIES WERE FOUND. CONCLUSION: BASED ON THE REPORTED INFORMATION AND DEVICE ANALYSIS, THE CUSTOMER¿S ¿PUSHWIRE KINK/DAMAGED¿ AND ¿RESISTANCE¿ REPORT WAS CONFIRMED AS THE PUSHER WIRE OF THE RETURNED PIPELINE FLEX DEVICE WAS DETACHED AT THE PROXIMAL WELD, AND THE BRAID ENDS WERE OPEN AND FRAYED. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. THE DAMAGE LIKELY OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE THE PIPELINE FLEX DEVICE THROUGH THE MARKSMAN CATHETER AGAINST RESISTANCE. HOWEVER, THE CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF RESISTANCE INCLUDE AN INCOMPATIBLE/DAMAGED CATHETER, SEVERE VESSEL TORTUOSITY, A LACK OF CONTINUOUS HEPARINIZED SALINE FLUSH DURING DELIVERY, AND THE USER PULLING BACK ON/TORQUING THE WIRE WHILE ADVANCING THE PIPELINE FLEX DEVICE THROUGH THE CATHETER. IN THIS EVENT, THE MARKSMAN CATHETER WAS COMPATIBLE WITH THE PIPELINE FLEX DEVICE AS IT HAS A LABELED INNER DIAMETER (ID) OF 0.027 INCHES, RULING OUT AN INCOMPATIBLE CATHETER AS A POTENTIAL CAUSE. THEREFORE, A DAMAGED CATHETER, SEVERE VESSEL TORTUOSITY, A LACK OF CONTINUOUS HEPARINIZED SALINE FLUSH DURING DELIVERY, OR THE USER PULLING BACK ON/TORQUING THE WIRE WHILE ADVANCING THE PIPELINE FLEX DEVICE IN THE CATHETER COULD HAVE CONTRIBUTED TO THE RESISTANCE FAILURE. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. 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 A MARKSMAN STENT CATHETER WAS INSERTED AND GUIDED VIA A GUIDEWIRE TO THE M1 SEGMENT. DURING PREPARATION FOR THE PIPELINE FLEX STENT, THE STENT PUSH ROD WAS FOUND TO BE SLIGHTLY KINKED DURING NORMAL HYDRATION. THE SURGEON REPORTED RESISTANCE MID CATHETER WHEN INSERTING THE STENT INTO THE STENT CATHETER, AND THE PROXIMAL PUSH ROD COMPLETELY KINKED DURING FURTHER INSERTION. THE STENT WAS WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 15 MM AND A 16 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS CONVENTIONAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NOTED AS NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL) AND WAS CONTINUOUSLY FLUSHED WITH HEPARINIZED SALINE. THE PIPELINE DID NOT BECOME STUCK AND WAS NOT DAMAGED, HOWEVER, THE MIDDLE SECTION OF THE PUSHWIRE HAD KINK DAMAGE. ANCILLARY DEVICES INCLUDED A 5F NAVIEN CATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE GRADUALLY INCREASE DURING DELIVERY OF THE PIPELINE. AFTER RESISTANCE WAS ENC OUNTERED, INCREASED FORCE WAS APPLIED DURING DELIVERY, WHICH LED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167304 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-500-35 D052736 00763000277291

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female