BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 23924687 · Received December 30, 2025

    Report

    Report Number
    2029214-2025-02698
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 22, 2025
    Report Date
    March 18, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536030725
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION RECEIVED. 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

    CONTINUATION OF D10: PRODUCT ID PED3-021-350-16 (D050415); PRODUCT ID FG13150-0615-2S (229938289); PRODUCT ID FG19120-1030-1S (231481250); 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. PRODUCT ANALYSIS: EQUIPMENT USED: VIDEO INSPECTION SYSTEM (M-85519), RULER (M-83361). AS FOUND CONDITION: THE PIPELINE VANTAGE DELIVERY SYSTEM WAS RETURNED INSIDE A BIOHAZARD BAG, AND A SHIPPING BOX. THE PHENOM 21 CATHETER WAS NOT RETURNED. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE DISTAL HYPOTUBE AND PTFE SHRINK TUBING WERE INTACT, WITH NO SIGNS OF ELONGATION. THE BRAID APPEARED TO BE DETACHED FROM THE PUSHWIRE. THE DISTAL AND PROXIMAL ENDS OF THE BRAID WERE FOUND FULLY OPENED AND NO DAMAGE. NO BENDS WERE FOUND WITH THE PUSHWIRE. NO DEFECTS WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, ADVANCED RESHEATHING MECHANISM, OR PROXIMAL BUMPER. NO OTHER ANOMALIES WERE OBSERVED. ¿ CONCLUSION: BASED ON THE RETURNED DEVICE, THE CUSTOMER REPORT OF "RESISTANCE DURING RESHEATHING" WAS NOT CONFIRMED, AS THE PIPELINE VANTAGE WAS RETURNED WITHOUT THE PHENOM 21 CATHETER. NO DAMAGE WAS FOUND WITH THE PIPELINE VANTAGE DELIVERY SYSTEM. THE PHENOM 21 APPEARED TO BE COMPATIBLE WITH THE PIPELINE VANTAGE AS IT HAS AN INNER DIAMETER OF 0.021". POSSIBLE CAUSES OF THE RESISTANCE INCLUDE VESSEL TORTUOSITY AND LACK OF CONTINUOUS FLUSH. HOWEVER, THE CUSTOMER INDICATED THAT VESSEL TORTUOSITY WAS NORMAL AND A CONTINUOUS FLUSH WITH HEPARINIZED SALINE WAS USED, ELIMINATING THEM OUT AS POTENTIAL CAUSES. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE CATHETER WAS NOT RETURNED, ANY CONTRIBUTION FROM THE CATHETER TO THE RESISTANCE ISSUE COULD NOT BE ASSESSED. H6. CODING UPDATED BASED ON ANALYSIS FINDINGS. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE RESHEATHING ISSUE OCCURRED ONLY WITH THE FIRST PIPELINE (PED3-021-350-20. LOT: D050452) AND THE PHENOM 21 MICRO CATHETER (FG13150-0615-2S, LOT: 229938289). RESISTANCE OCCURRED WITH THE PIPELINE IN THE DISTAL END OF THE PHENOM 21 MICROCATHETER. IT WAS NOTED THAT CONTINUOUS FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE AS INDICATED IN THE IFU. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE, NOR TO THE PHENOM21 OR PHENOM PLUS CATHETERS. THE SECOND PIPELINE WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ISSUE REPORTED INVOLVING THE PHENOM PLUS CATHETER (FG19120-1030-1S, LOT: 231481250) OR THE SECOND/IMPLANTED PIPELINE (PED3-021-350-16, LOT: D050415).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY FLOW DIVERTER DEVICE FOR THE TREATMENT OF AN UNRUPTURED, FUSIFORM CAROTID TIP ANEURYSM (MAXIMUM DIAMETER 5 MM, NECK DIAMETER 4 MM), IT WAS NOT POSSIBLE TO RESHEATH THE DEVICE DURING THE PROCEDURE, DESPITE NO VISUAL EVIDENCE OF TWISTING. MULTIPLE DEVICES WERE INVOLVED. ATTEMPTS TO RESHEATH THE DEVICE OUTSIDE THE SYSTEM WERE ALSO UNSUCCESSFUL, AND UPON OPENING, INCREASED RADIOPACITY WAS OBSERVED AT THE ZONE INVOLVED IN THE UNSUCCESSFUL RESHEATHING PROCESS. THE PROCEDURE WAS PERFORMED USING TRIAXIAL ACCESS VIA THE FEMORAL ARTERY (DIAMETER 8 MM) WITH NORMAL VESSEL TORTUOSITY, AND DUAL ANTIPLATELET THERAPY (ASA AND PLAVIX) WAS ADMINISTERED. GUIDE CATHETER (INFINITY PLUS) AND GUIDEWIRE (SYNCRO) WERE USED, AND ALL DEVICES AND ACCESSORIES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS REPORTED AS GOOD. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE LANDING ZONE WAS 3.3MM DISTAL AND 3.5MM PROXIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259413 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-021-350-20 D050452 00847536030725

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male SEE H11...