BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 15720481 · Received November 3, 2022

    Report

    Report Number
    2029214-2022-01871
    Event Type
    Injury
    Date Received
    November 3, 2022
    Date of Event
    January 27, 2018
    Report Date
    November 2, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT EXPERIENCED ADVERSE EVENT OF SEVERE HEADACHE WITH DROWSINESS AND HEMIPARESIS POST PROCEDURE AND BOTH OF THEM WERE RESOLVED ON THE SAME DAY. THE PIPELINE WAS IMPLANTED SUCCESSFULLY AND COILS WERE ALSO USED JUST TO SPEED UP THE PROCESS OF THROMBOSING THE ANEURYSM WITHOUT ANY PROBLEMS. POST PROCEDURAL IMAGING SHOWED SIGNIFICANT STATUS AND ANEURYSM OCCLUSION (RAYMOND AND ROY) WAS CLASS 3. THE PATIENT WAS DISCHARGED HOME A COUPLE OF DAYS LATER FOR SELF CARE. AT FOUR MONTH FOLLOW UP, IT WAS REPORTED THAT THERE WAS NO STASIS, BUT ALSO NO NEW EVENTS. THE STATUS WAS GIVEN AT 6 MONTH FOLLOW UP. NO STASIS AND ALSO NO NEW EVENTS. THE EVENTS WERE REPORTED TO BE POSSIBLY RELATED TO THE INDEX PROCEDURE. PATIENT 4213001 OF THE INSPIRE STUDY WAS REPORTED TO HAVE EXPERIENCE AN AE HEADACHE WITH DROWSINESS AND DISORIENTATION WHICH HAS BEEN ASSESSED BY SITE TO HAVE CAUSAL RELATIONSHIP TO INDEX PROCEDURE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR SIDEWALL ANEURYSM MEASURING 22MM X 22MM X 18MM X 6MM (DIA, HGT, WTH, NCK) LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THE PATIENT HAS A HISTORY OF CONTROLLED HYPERTENSION. PATIENT HAD HISTORY OF HYPERTENSION. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HOSPITALIZED. IT HAD A CAUSAL RELATIONSHIP TO THE PROCEDURE. THE EVENT WAS RESOLVED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498288 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-475-25 A326842

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization