BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 18211397 · Received November 27, 2023

    Report

    Report Number
    2029214-2023-02281
    Event Type
    Death
    Date Received
    November 27, 2023
    Date of Event
    February 9, 2023
    Report Date
    November 27, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. NO SPECIFIC DEVICE INFORMATION PROVIDED. 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

    DOLAS, I., UNAL, T. C., GULSEVER, C. I., SAHIN, D., HUSEYNOV, H., BARBUROGLU, M., OZTURK, O., CAN, H., ADIYAMAN, A. E., DAGDEVIREN, H. E., SABANCI, P. A., AYDOSELI, A., ARAS, Y., SENCER, A., SENCER, S. ENDOVASCULAR TREATMENT OF POSTERIOR CIRCULATION ANEURYSMS: RESULTS FROM A SINGLE-TEAM EXPERIENCE OF 81 CASES INCLUDING 13 FLOW DIVERSION TREATMENT. NEUROCIRUGIA. 2023. 34(4):168¿176. DOI: 10.10 16/J.NEUCIE.2022.11.022 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH AXIUM COILS, SOLITAIRE STENTS USED IN STENT-ASSISTED COILING, AND PIPELINE FLOW DIVERTERS. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT THE RESULTS OF A SERIES OF ENDOVASCULARLY TREATED POSTERIOR CIRCULATION ANEURYSMS. A TOTAL OF 81 PATIENTS WHO UNDERWENT ENDOVASCULAR TREATMENT OF POSTERIOR CIRCULATION ANEURYSMS. AMONG THE INCLUDED PATIENTS, 50 WERE FEMALE AND 31 WERE MALE, AND THE MEAN AGE WAS 57.4 YEARS. AMONG THE 81 ANEURYSMS, 40 ANEURYSMS WERE TREATED WITH STENT-ASSISTED COILING, 1 ANEURYSM WAS TREATED BY PARENT ARTERY OCCLUSION, 2 ANEURYSMS WERE COILED USING BALLOON ASSISTANCE, 24 ANEURYSMS WERE COILED PRIMARILY, 1 PATIENT HAD AN UNSUCCESSFUL TREATMENT ATTEMPT, AND 13 ANEURYSMS WERE TREATED WITH FLOW-DIVERTER STENTS OR STENT MONOTHERAPY. IT IS UNCLEAR HOW MANY OF THESE EVENTS OCCURRED WITH THE USE OF AXIUM, SOLITAIRE, OR PIPELINE DEVICES. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE AXIUM, SOLITAIRE, OR PIPELINE DEVICES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: ONE PATIENT WITH A PREVIOUSLY UNRUPTURED VERTEBRAL ARTERY ANEURYSM TREATED WITH FLOW DIVERTERS DIED DUE TO COMPLICATIONS OF ANEURYSM RUPTURE 24 HOURS AFTER TREATMENT. THREE ELDERLY PATIENTS WITH BASILAR TRUNK ANEURYSMS TREATED WITH FLOW DIVERTERS DIED DUE TO POSTOPERATIVE ISCHEMIC COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259407 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death