BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 25068086 · Received May 4, 2026

    Report

    Report Number
    2029214-2026-00799
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000276928
    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.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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 C7 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 1.3 MM AND A 1.0 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.06MM DISTALLY AND 4.0MM PROXIMALLY. IT WAS UNKNOWN IF A DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT ON THE EVENING OF APRIL 28, THE OPERATOR USED A 6F LONG SHEATH IN COMBINATION WITH A 5F 115 CM INTERMEDIATE CATHETER. THE PHENOM 27 WAS POSITIONED TO THE C7 SEGMENT, AND THE PED STENT WAS ADVANCED TO THE DISTAL POSITION. THE MICROCATHETER WAS WITHDRAWN UNTIL THE DISTAL GUIDEWIRE TIP WAS EXPOSED. WHILE STABILIZING THE DELIVERY WIRE, THE MICROCATHETER WAS FURTHER WITHDRAWN TO CONTINUE RELEASING THE PIPELINE DEVICE. THE OPENING AT THE PROXIMAL CURVE WAS NOT IDEAL. SYSTEM TENSION WAS ADJUSTED BY RETRACTING THE INTERMEDIATE CATHETER TO RELEASE TENSION, WHILE ADVANCING THE DELIVERY WIRE AND PERFORMING PUSH¿PULL DEPLOYMENT. THE PROXIMAL END OF THE STENT DID NOT OPEN THROUGHOUT THE PROCEDURE. AS A RESULT, PRODUCT DAMAGE WAS REQUESTED. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN AND WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICRO CATHETER FROM THE PATIENT. AFTER THE PROCEDURE, THE ANGIOGRAPHIC RESULT SHOWED THE STENT WAS RE-IMPLANTED; CONTRAST AGENT WAS RETAINED WITHIN THE ANEURYSM SAC, AND THE STENTED SEGMENT WAS FULLY EXPANDED. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT, "ANOTHER STENT WAS USED INSTEAD AND IMPLANTED, AND THE PROCEDURE WAS COMPLETED." NO CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN WERE IDENTIFIED. RESISTANCE WAS ENCOUNTERED DURING THE DELIVERY PROCESS. NO DAMAGE WAS OBSERVED ON THE STENT BRAID/PUSHWIRE OR THE PHENOM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54169 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-400-30 B713076 00763000276928

    Patients

    Seq Age Sex Outcome Treatment
    1