BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 8304936 · Received February 5, 2019

    Report

    Report Number
    2029214-2019-00088
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 8, 2019
    Report Date
    March 3, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX WITH SHIELD TECH COLLAPSED ON THE PROXIMAL END AFTER APPROXIMATELY 45% OF IT WAS OPENED. PRIOR TO THE EVENT, THE MARKSMAN AND PIPELINE WERE ADVANCED ACROSS THE ANEURYSM AND THEN IT WAS DEPLOYED AND THE EVENT OCCURRED. INJECTIONS WERE MADE IN ALL PROJECTIONS AND THEY FOUND THE TWIST OF THE DIVERSE R (TWIST). THEY TRIED ALL THE MANEUVERS TO MASSAGE THE MESH OPEN WITH THE MICROCATHETER AND TRY TO LOOSEN IT OPEN BUT WITHOUT SUCCESS. IT WAS DECIDED BY THE MEDICAL TEAM TO REMOVE THE ENTIRE SYSTEM AND ANOTHER PIPELINE (SAME SIZE) WAS USED WITH THE SAME MICROCATHETER AND THE PIPELINE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 4.3 MM X 2.2 MM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE DISTAL AND PROXIMAL LANDING ZONE WAS 4.1 MM X 3.8 MM. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY. PATIENT WAS ON DUAL ANTIPLATELET THERAPY. NO IMAGES ARE AVAILABLE FOR REVIEW. ANCILLARY DEVICES: MARKSMAN FA-55150-1030 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99218 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PED2-450-25 A573399

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR