BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 18998444 · Received March 28, 2024

    Report

    Report Number
    2029214-2024-00535
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 22, 2024
    Report Date
    April 19, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PED3-027-450-16 (B242896). 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 TWO PIPELINES FAILED TO OPEN IN THE MIDDLE SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE RIGHT CAROTID SYPHON WITH A MAX DIAMETER OF 7MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 3MM DISTALLY AND 4.2MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND PRU LEVEL WAS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT THE PIPELINES WERE OPEN IN A STRAIGHT SEGMENT, DROPPED AND THEY CONTINUED THE OPENING OF THE DEVICE. THE MIDDLE PART OF THE STENTS DIDN'T WANT TO OPEN CORRECTLY DESPITE A LOT OF MANEUVERS (RESHEATING AND PUSHING THE DEVICE). THE PIPELINES WERE NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINES HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WERE RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICE REQUIRED TO OPEN THE PIPELINE. THE PIPELINES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PIPELINES WERE USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.  ANCILLARY DEVICES INCLUDE A NEURON MAX SHEATH, SOFIA EX GUIDE CATHETER, PHENOM 27 MICROCATHETER, SYNCHRO 14 GUIDEWIRE, AND MICROPLEX COSMOS 18 COILS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE WAS PROBABLY THE TORTUOSITY OF THE VESSELS WHICH CONTRIBUTED TO THIS DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494728 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-027-450-14

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female SEE H11...