BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 12640019 · Received October 15, 2021

    Report

    Report Number
    2029214-2021-01285
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    October 6, 2021
    Report Date
    January 4, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE PIPELINE FLEX BRAID WAS RETURNED FOR ANALYSIS. THE PIPELINE FLEX BRAID WAS RETURNED ALREADY DETACHED FROM THE PUSHER; THEREFORE, THE BRAID ENDS (PROXIMAL, DISTAL) COULD NOT BE IDENTIFIED. THE PUSHER WAS NOT RETURNED WITH THE BRAID. BOTH ENDS OF THE BRAID WERE FOUND OPEN AND IN GOOD CONDITION. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT COULD NOT BE CONFIRMED, AND THE CAUSES COULD NOT BE DETERMINED. NO DEFECT WAS FOUND WITH THE RETURNED BRAID THAT WOULD HAVE CONTRIBUTED TO THE EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED 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. 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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 A REPORT THAT THE STENT CANNOT BE RESHEATHED. THERE WAS ALSO MOVEMENT DURING PLACEMENT (DIFFICULT PLACEMENT/POSITIONING). THERE WERE NOT MULTIPLE PIPELINE DEVICES BEING USED WHEN THE MOVEMENT OCCURRED. THERE WAS FRICTION/DIFFICULTY DURING DELIVERY OR POSITIONING. THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION. PIPELINE WAS NOT IMPLANTED BECAUSE DURING THE POSITIONING, THE STENT COULD NOT BE RE-SHEATHED. THE PHYSICIAN THEN CHANGE TO ANOTHER MARKSMAN MICROCATHETER AND NEW PIPELINE AND IT WAS SUCCESSFULLY IMPLANTED. THE PIPELINE USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE PIPELINE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER AND AVIGO GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535918 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-400-18 B048846

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female