BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 15950552 · Received December 9, 2022

    Report

    Report Number
    2029214-2022-02090
    Event Type
    Death
    Date Received
    December 9, 2022
    Date of Event
    November 12, 2019
    Report Date
    December 9, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED PATIENT AGE (53 YEARS) IS REPRESENTATIVE OF THE MEAN AGE OF ALL PATIENT INCLUDED IN THE LITERATURE ARTICLE STUDY INFORMATION. REPORTED PATIENT SEX (FEMALE) IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS (17/22) WHO WERE INCLUDED IN THE LITERATURE ARTICLE STUDY INFORMATION. SEPARATE REPORTED WILL BE SUBMITTED FOR THE MARKSMAN MICROCATHETER, ECHELON MICROCATHETER, AND NAVIEN INTRACRANIAL SUPPORT CATHETERS AND FOR THE SERIOUS INJURY EVENT(S) REPORTED IN THE ARTICLE. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    2022-11-21 LIT (HCP, FOR): WANG, Z., TIAN, Z., LI, W., WANG, J., ZHU, W., ZHANG, M., ZHANG, Y., LIU, J., WANG, K., ZHANG, Y., <(>&<)> YANG, X. (2019). VARIATION OF MASS EFFECT AFTER USING A FLOW DIVERTER WITH ADJUNCTIVE COIL EMBOLIZATION FOR SYMPTOMATIC UNRUPTURED LARGE AND GIANT INTRACRANIAL ANEURYSMS. FRONTIERS IN NEUROLOGY, 10, 1191. HTTPS://DOI.ORG/10.3389/FNEUR.2019.01191. MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND THAT 22 PATIENTS WITH 22 UNRUPTURED LARGE OR GIANT ANEURYSMS WITH RELATED MASS EFFE CT/COMPRESSION SYMPTOMS WERE TREATED WITH FLOW DIVERTER WITH LOOSE ADJUNCTIVE COILING. 17/22 PATIENTS WERE FEMALE AND THE MEAN PATIENT AGE WAS 53 YEARS. THE PIPELINE EMBOLIZATION DEVICE (PED) WAS NOTED TO BE THE MOST COMMONLY USED FLOW DIVERTER AT THE FACILITY. IT WAS ADDITIONALLY NOTED THAT 5F NAVIEN INTRACRANIAL SUPPORT CATHETER, MARKSMAN MICROCATHETER, AND ECHELON MICROCATHETER WERE USED IN THE FLOW DIVERTER + COILING PROCEDURES. MULTIPLE MANUFACTURER'S COIL WERE USED, INCLUDING AXIUM COILS. HOWEVER, THE TYPE OF COILS USED IN EACH EVENT WAS NOT SPECIFIED. THERE WERE NO REPORTED DEVICE MALFUNCTIONS OR INTRA-OPERATIVE ISSUES. ADVERSE PATIENT EVENTS NOTED IN THE ARTICLE INCLUDED: FIVE OF THE 22 PATIENTS (22.72%) SHOWED NO IMPROVEMENT OF ANEURYSM SIZE/STATUS POST-OPERATIVELY. FOUR PATIENTS (18.18%) SHOWED WORSENING NEUROLOGICAL SYMPTOMS COMPARED WITH THEIR PREOPERATIVE STATUS, INCLUDING TWO (9.09%) WITH ISCHEMIC COMPLICATIONS. ALL FOUR OF THESE PATIENTS PRESENTED WITH MORE SEVERE COMPRESSIONAL SYMPTOMS THAN THEIR PREOPERATIVE STATE. ONE PATIENT (4.55%) DIED OF SUBARACHNOID HEMORRHAGE RELATED TO DELAYED ANEURYSM RUPTURE DIAGNOSED AT A LOCAL CENTER 2 MONTHS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908867 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Death