BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 25318601 · Received May 28, 2026

    Report

    Report Number
    2029214-2026-00975
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 24, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000449568
    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 PIPELINE FAILURE TO OPEN. THE PATIENT WAS UNDERGOING FLOW-DIVERTING STENT IMPLANTATION FOR TREATMENT OF A SACCULAR, UNRUPTURED, LEFT INTERNAL CAROTID ARTERY, C6 SEGMENT ANEURYSM. THE LANDING ZONE/ANCHORING POINT WAS 4.3 MM DISTALLY AND 4.9 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AT A PLATELET REACTIVITY UNITS (PRU) LEVEL OF 110. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THAT THE PARENT ARTERY AND DISTAL VESSEL WERE PATENT. IT WAS REPORTED THAT A PIPELINE (PED2-500-20) FLOW-DIVERTING STENT WAS SELECTED FOR IMPLANTATION. A 6F DELIVERY CATHETER COMBINED WITH A 5F 115 NAVIEN WAS USED FOR ACCESS. THE PHENOM 27 STENT CATHETER WAS ADVANCED OVER A GUIDEWIRE TO THE M1 SEGMENT. AFTER POSITIONING THE PROTECTIVE SHEATH FIRMLY AGAINST THE PHENOM 27 HUB, THE STENT WAS DELIVERED TO THE M1 SEGMENT. ONCE THE STENT CATHETER CAME OUT, AN ATTEMPT WAS MADE TO OPEN THE TIP END. THE TIP END OF THE STENT WAS RELEASED FOR ABOUT 5 MM BUT FAILED TO OPEN. FURTHER RELEASE WAS ATTEMPTED, BUT IT STILL DID NOT OPEN. THE STENT WAS THEN PULLED BACK TO THE INTERNAL CAROTID ARTERY FOR REPOSITIONING, AND REPEATED ATTEMPTS WERE UNSUCCESSFUL. THE SYSTEM WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A STENT FROM ANOTHER MANUFACTURER. THERE WAS FAILURE TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT POSITIONED IN A BEND AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. IT IS UNKNOWN IF THERE WERE ANY ADDITIONAL STEPS OR OTHER DEVICES USED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER, AND FROM THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PIPELINE 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). ANCILLARY DEVICES INCLUDE A 6F DELIVERY CATHETER, A 5F 115 NAVIEN, AND A PHENOM 27 STENT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359031 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-500-20 D044999 00763000449568

    Patients

    Seq Age Sex Outcome Treatment
    1