BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 20892742 · Received December 10, 2024

    Report

    Report Number
    2029214-2024-02269
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 17, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000284244
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PED2-375-16 (LOT: B781634); 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THERE WERE NO REPORTED ISSUES IDENTIFIED WITH THE CATHETER USED. SITE REPORTED COMPLETE WALL AP POSITION, NECK COVERAGE AT THE END OF PROCEDURE. R & R WAS CLASS 3. COMPLETE STASIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE, THE DEVICE WAS PARTIALLY DEPLOYED IN THE WRONG POSITION WITHIN THE RIGHT HEMISPHERE, C6 SEGMENT, BIFURCATION BRANCH. THE ANEURYSM WAS UNRUPTURED WITH A SACCULAR MORPHOLOGY, A MAXIMUM DIAMETER OF 2.8MM, AND A NECK DIAMETER OF 2.0MM. THE LANDING ZONE ARTERY SIZE WAS 3.4MM DISTALLY AND 3.7MM PROXIMALLY. AN ATTEMPT WAS MADE TO RESHEATH AND ADVANCE THE DEVICE IN THE PARENT VESSEL, BUT IT COULD NOT PASS OVER THE DISTAL WIRE. CONSEQUENTLY, THE DEVICE WAS REMOVED, AND A NEW ONE WAS USED. THE PATIENT'S MEDICAL HISTORY INCLUDED A FAMILY HISTORY OF STROKE/TIA, CONTROLLED HYPERTENSION, VITAMIN D DEFICIENCY, COVID-19, A HISTORY OF TRANSIENT ISCHEMIC ATTACK, ENVIRONMENTAL AND SEASONAL ALLERGIES, ACQUIRED HYPOTHYROIDISM, BIPOLAR AFFECTIVE DISORDER IN REMISSION, ASTHMA, CHRONIC FATIGUE, CONSTIPATION, INSOMNIA, MENOPAUSAL SYMPTOMS, MIGRAINES, RECURRENT COLD SORES, URGE INCONTINENCE OF URINE, AND URINARY TRACT INFECTIOUS DISEASE. THE OUTCOME OF THE PROCEDURE WAS NOT SPECIFIED. COMPLETE STASIS AND NECK COVERAGE WAS NOTED AT THE END OF THE PROCEDURE. POST IMPLANT ANEURYSM OCCLUSION (RAYMOND AND ROY) AT THE END OF THE PROCEDURE WAS CLASS 3. THE ACCESS WAS VIA FEMORAL RIGHT. RIST WAS NOT USED. THE STUDY DEVICE WAS SUCCESSFULLY IMPLANTED IN THE SUBJECT. WALL APPOSITION WAS ACHIEVED AFTER REPLACEMENT. SIDE BRANCHES WERE COVERED BY THE PIPELINE DEVICE (OPHTHALMIC). NO DEVICE FLATTENING OR TWISTING WAS NOTED. ANCILLARY DEVICES: GUIDE CATHETER 7 FRENCH 072 ARMADILLO, MICROCATHETER MEDTRONIC PHENOM 027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504988 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-375-14 B333314 00763000284244

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female SEE H11...