BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 17744210 · Received September 14, 2023

    Report

    Report Number
    2029214-2023-01708
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    November 3, 2022
    Report Date
    September 14, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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

    TONG, X., HE, Z., HAN, M., FENG, X., DUAN, C., LIU, A. FLOW DIVERSION TREATMENT FOR GIANT INTRACRANIAL SERPENTINE ANEURYSMS. FRONT. AGING NEUROSCI. 2022. 14:988411. DOI: 10.3389/FNAGI.2022.988411. SUMMARY: GIANT SERPENTINE ANEURYSMS (GSAS) ARE AMONG THE MOST COMPLEX AND CHALLENGING TYPE OF INTRACRANIAL ANEURYSMS. SURGICAL CLIPPING, BYPASS, OR ENDOVASCULAR PARENT ARTERY OCCLUSION HAS BEEN THE MAIN TREATMENT OF GSAS IN THE PAST. HOWEVER, STUDIES ON FLOW DIVERSION (FD) ARE LIMITED. THEREFORE, WE REPORTED OUR EXPERIENCE WITH PATIENTS WITH GSAS TREATED WITH FD. PATIENTS WITH GSAS TREATED WITH FD FROM 2012 TO 2020 IN OUR SINGLE CENTER WERE RETROSPECTIVELY REVIEWED. ANGIOGRAPHIC OUTCOMES WERE GRADED ACCORDING TO THE O¿KELLY¿MAROTTA SCALE AS COMPLETE OCCLUSION (D), TRACE FILLING (C), ENTRY REMNANT (B), OR ANEURYSM FILLING (A). CLINICAL OUTCOMES WERE ASSESSED USING THE MODIFIED RANKIN SCALE (MRS) SCORE. WE ALSO COLLECTED THE PATIENTS¿ TREATMENT DETAILS AND PERIOPERATIVE COMPLICATIONS. THIRTEEN PATIENTS WITH 14 ANEURYSMS WERE INCLUDED, INCLUDING THREE IN THE ANTERIOR CIRCULATION AND 11 IN THE POSTERIOR CIRCULATION. GRADES B¿D WERE FOUND IN 72.7% (8/11) OF THE GSAS. GOOD PROGNOSIS (MRS SCORE, 0¿2) WAS FOUND IN 66.7% (8/12) AND 50.0% (6/12) OF THE PATIENTS AT THE 6-MONTH AND LATEST FOLLOW-UP, RESPECTIVELY. PARENT ARTERY OCCLUSION WAS FOUND IN THREE CASES OF GSAS. FIVE POSTOPERATIVE COMPLICATIONS WERE OBSERVED, INCLUDING TWO MINOR COMPLICATIONS AND THREE MAJOR COMPLICATIONS. ALTHOUGH RECONSTRUCTIVE TREATMENT WITH FD COULD BE CONSIDERED AS ONE OF THE TREATMENT STRATEGIES FOR PATIENTS WITH BOTH ANTERIOR AND POSTERIOR CIRCULATION GSAS, HOWEVER, THE RISK OF COMPLICATIONS AND PARENT ARTERY OCCLUSION SHOULD BE CONSIDERED. REPORTED EVENTS: 2 PATIENTS EXPERIENCED TRANSIENT ISCHEMIC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183203 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown