BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 24551618 · Received March 9, 2026

    Report

    Report Number
    2029214-2026-00394
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 15, 2026
    Report Date
    March 9, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536030626
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 INFORMATION REGARDING A PHENOM 21 MICROCATHETER THAT HAD RESISTANCE DURING RETRIEVAL OF THE GUIDEWIRE. THE PATIENT WAS UNDERGOING A PROCEDURE FOR TELESCOPING OF AT LEAST 10 PIPELINE VANTAGE EMBOLIZATION DEVICE STENTS TO TREAT A BASILAR ARTERY UNRUPTURED FUSIFORM ANEURYSM. PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, THE DOCTOR WANTED TO REMOVED THE GUIDEWIRE BY PULLING IT INTO THE PHENOM MICROCATHETER BUT COULD NOT DO SO; THERE WAS RESISTANCE AT THE DISTAL END OF THE PHENOM 21 MICROCATHETER. ADJUSTMENT OF THE CATHETER AND GUIDEWIRE WAS ATTEMPTED BUT THE ISSUE WAS NOT RESOLVED. THE SYSTEM WAS REMOVED TOGETHER AND THE PHENOM MICROCATHETER WAS NOTED TO HAVE ACCORDION-TYPE DAMAGE. THE MICROCATHETER WAS REPLACED WITH ANOTHER PHENOM 21 MICROCATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT; POST PROCEDURE ANGIOGRAPHY SHOWED VERY GOOD RESULTS. ANCILLARY DEVICES: SYNCHRO GUIDEWIRE, SOFIA 5F GUIDE CATHETER, PIPELINE VANTAGE WITH SHIELD EMBOLIZATION DEVICES (PED3-021-350-20 LOT: D050452 , PED3-021-350-25 LOT: B717131, PED3-021-300-20 LOT: D043019, PED3-021-300-14 LOT: B631125, PED3-021-300-12 LOT: B551608, PED3-021-300-14 LOT: B631125, PED3-021-325-20 LOT: B787131, PED3-021-350-12 LOT: B808099, PED3-021-350-16 LOT: D027551 , PED3-021-325-14 LOT: B812490, PED3-021-325-16 LOT: D039142) ADDITIONAL INFORMATION RECEIVED REPORTED IN ACTUALITY THE RESISTANCE OCCURRED DURING RETRIEVAL OF THE FIFTH PIPELINE USED IN THE PROCEDURE (PED3-021-325-16 LOT: D039142). THE DOCTOR TRIED HARD TO REMOVE THE PIPELINE TIP WIRE BUT COULD NOT AND THE PHENOM21 CATHETER DEVELOPED ACCORDION-SHAPE DAMAGE. IT WAS THOUGHT THAT THE SLEEVE MAY HAVE BEEN STUCK BUT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THEY HAD TO REMOVE THE COMPLETE SYSTEM AND REPLACE THE PHENOM 21 MICROCATHETER. THE PROCEDURE THEN CONTINUED WITH THE OTHER PIPELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612347 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-021-325-16 D039142 00847536030626

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female