BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 25057457 · Received May 1, 2026

    Report

    Report Number
    2029214-2026-00795
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 1, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000277017
    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 OF ONE PIPELINE STENT'S FAILURE TO OPEN, ANOTHER PIPELINE STENT'S KINKING AND RESISTANCE, AND PHENOM 27 MICROCATHETER RESISTANCE. THE PATIENT WAS UNDERGOING INTRACRANIAL ANEURYSM FLOW DIVERSION THERAPY SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED, LEFT OPHTHALMIC ARTERY SEGMENT ANEURYSM. IT HAD A MAX DIAMETER OF 6 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE WAS 3.6 MM DISTALLY AND 4.5 MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AT A PLATELET REACTIVITY UNITS (PRU) NORMAL RANGE LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED UNOBSTRUCTED BLOOD VESSEL. IT WAS REPORTED THAT BASED ON THE ANEURYSM LOCATION AND VESSEL DIAMETER, THE OPERATOR SELECTED AN APPROPRIATE STENT AND PERFORMED A STANDALONE FLOW-DIVERTER STENT IMPLANTATION. THE INTERMEDIATE CATHETER WAS POSITIONED IN THE CAVERNOUS SEGMENT, AND THE MICROCATHETER WAS PLACED IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. AFTER FULL HYDRATION OF THE PED2-450-25 STENT, THE FLOW-DIVERTER STENT WAS DELIVERED. THE OPERATOR REPORTED THAT THE DELIVERY RESISTANCE WAS SLIGHTLY GREATER THAN USUAL. THE PED2-450-25 STENT WAS DELIVERED TO THE STRAIGHT SEGMENT OF M1, AND THE MICROCATHETER WAS WITHDRAWN TO EXPOSE 6-8 MM OF THE STENT TIP, BUT THE TIP END OF THE STENT STILL DID NOT FULLY OPEN. THE OPERATOR PUSHED THE STENT TO INCREASE TENSION; THE DISTAL PORTION OF THE STENT OPENED, BUT THE TIP REMAINED UNOPENED. THE OPERATOR THEN PULLED BACK ON THE PED2-450-25 STENT, BUT THE TIP STILL DID NOT OPEN. THE STENT WAS SUBSEQUENTLY RETRACTED AND REPOSITIONED TO THE ORIGINAL LOCATION IN THE INTERNAL CAROTID ARTERY FOR REDEPLOYMENT. AFTER THE TIP END OPENED, FL UOROSCOPY SHOWED THAT THE TIP END OF THE PED2-450-25 STENT WAS NOT WELL APPOSED TO THE VESSEL WALL. THE OPERATOR DECIDED TO REMOVE THE STENT, AND UPON EXTRACORPOREAL INSPECTION, THE TIP END OF THE STENT WAS FOUND TO BE ROUGH. THE PIPELINE PED2-450-25 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). THE OPERATOR THEN ADVANCED THE MICROCATHETER AGAIN INTO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY AND SELECTED A NEW STENT, PED-425-30. AFTER FULLY HYDRATING THE STENT, IT WAS DELIVERED INTO THE MICROCATHETER. THE OPERATOR REPORTED MARKED RESISTANCE DURING DELIVERY. THE PED-425-30 STENT WAS DELIVERED TO THE STRAIGHT SEGMENT OF M1, AND THE MICROCATHETER WAS WITHDRAWN, THE TIP END OF THE STENT OPENED SMOOTHLY. THE STENT WAS WITHDRAWN AS A WHOLE TO THE DISTAL END OF THE INTERNAL CAROTID ARTERY. AFTER PROPER POSITIONING, THE OPERATOR PUSHED THE STENT TO DEPLOY IT. THE DISTAL END OF THE STENT OPENED SMOOTHLY, BUT KINKING OCCURRED IN THE MID SEGMENT OF THE STENT. DESPITE MANEUVERS SUCH AS ROTATION AND PUSHING/PULLING, THE KINKING COULD NOT BE RESOLVED. THE OPERATOR THEN DECIDED TO RETRIEVE THE PED-425-30 STENT BUT FOUND THAT THE STENT HAD DETACHED. COORDINATED MANIPULATION OF THE MICROCATHETER AND PUSH ROD COULD NOT RETRIEVE THE STENT INTO THE MICROCATHETER. THE OPERATOR HAD TO ADVANCE THE INTERMEDIATE CATHETER UP, RETRIEVE MOST OF THE DISTAL PORTION OF THE STENT INTO THE INTERMEDIATE CATHETER, AND THEN REMOVE THE ENTIRE SYSTEM. THE PIPELINE PED-425-30 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). SIGNIFICANT RESISTANCE WAS FELT AS THE STENT PASSED THROUGH THE PHENOM 27 MICROCATHETER. THE RESISTANCE WAS IN THE DISTAL PORTION OF THE CATHETER. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A TGC070-06-115 GUIDE CATHETER AND A PHENOM 27 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63150 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-425-30 B700539 00763000277017

    Patients

    Seq Age Sex Outcome Treatment
    1