BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 24800243 · Received April 7, 2026

    Report

    Report Number
    2029214-2026-00614
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 5, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536036246
    PMA / PMN Number
    P100018
    Removal / Correction Number
    Z-1246-2025
    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

    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 TWO PIPELINE VANTAGE DEVICES THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE BASILAR ARTERY WITH A MAX DIAMETER OF 4.3MM AND A 5.3MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 1.3MM DISTAL AND 1.8MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NONE. THERE ARE IMAGES AVAILABLE FOR REVIEW. IT WAS REPORTED THAT DURING FLOW-DIVERTING STENT IMPLANTATION FOR AN ANEURYSM, THE ANEURYSM WAS A FUSIFORM ANEURYSM LOCATED IN THE P2 SEGMENT. THE INTERMEDIATE CATHETER WAS IN PLACE, AND THE MICROCATHETER WAS POSITIONED APPROPRIATELY. A 250-14 STENT WAS SELECTED. AFTER DELIVERING THE STENT TO THE TARGET POSITION, THE TIP END OF THE STENT FAILED TO OPEN PROPERLY. DESPITE CONTINUED DEPLOYMENT, THE STENT REMAINED ROD-SHAPED. IT WAS RETRIEVED AND REDEPLOYED THREE TIMES IN AN ATTEMPT TO ACHIEVE OPENING, BUT IT STILL FAILED TO OPEN. THE MICROCATHETER AND STENT WERE REPLACED AND THE REPLACEMENTS WERE ADVANCED TO THE TARGET POSITION. A 250-16 STENT WAS SELECTED. AFTER DEPLOYMENT, THE STENT STILL REMAINED ROD-SHAPED. THE OPERATOR ATTEMPTED TWICE REPEATEDLY, BUT THE STENT FAILED TO OPEN. AFTER TWO UNSUCCESSFUL ATTEMPTS TO RETRIEVE, THE MICROCATHETER AND STENT WERE REMOVED. ANOTHER ASSISTING STENT WAS USED INSTEAD FOR EMBOLIZATION, AND THE PROCEDURE CONTINUED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE DEVICES WERE NOT USED FOR ANY INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE A 6F115 TON-BRIDGE MEDICAL GUIDE CATHETER AND A PHENOM 21 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587552 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-021-250-16 D066372 00847536036246

    Patients

    Seq Age Sex Outcome Treatment
    1