BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 24987939 · Received April 24, 2026

    Report

    Report Number
    2029214-2026-00737
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 4, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536002166
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PED2-300-10 (D020196); PRODUCT ID FG15150-0615-1S (B)(6). 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 THAT THE PED2 WERE SUCCESSFULLY IMPLANTED, THE WITHDRAWAL OF THE DELIVERY WIRES TURNED OUT TO BE DIFFICULT BECAUSE THE WINGS DID NOT PASS THROUGH THE CATHETER. THEY COULD BE WITHDRAWN. THERE WAS PUSHWIRE/CAPTURE COIL STUCK DURING RETRACTION. THE PUSHWIRE WAS NOT ROTATED DURING REMOVAL. THERE WAS NO DAMAGE TO THE CATHETER. THERE WAS PUSHWIRE DAMAGE FOR PED WITH LOT D020196. THERE WAS NO PUSHWIRE DAMAGE FOR PED WITH LOT D005232. THE CAPTURE COIL WAS NOT DAMAGED DURING REMOVAL. THERE WAS NO FRICTION OR DIFFICULTY. THE PIPELINE WAS IMPLANTED IN THE PATIENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINES WERE USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A ANEURYSM CARE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SUCCESSFUL.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT IDENTIFIED. THE CATHETER WAS NOT THE PROBLEM, IT WAS THE WIRE. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299930 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-300-14 D005232 00847536002166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...