BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 16479672 · Received March 3, 2023

    Report

    Report Number
    2029214-2023-00401
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    April 1, 2014
    Report Date
    March 3, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LUCKING H, STUFFER, GOELITZ P, ENGELHORN T, BRANDNER S, KURAMATSU J, LANG S, SCHMIDT M, DOERFLER A. STENT-ASSISTED COILING USING LEO+ BABY STENT. CLINICAL NEURORADIOLOGY. 2021; 31:409¿416. DOI: 10.1007/S00062-020-00904-3. 58 YEARS IS THE AVERAGE AGE OF THE PATIENTS WHO PARTICIPATED IN THE STUDY. FEMALE IS THE MAJORITY OF THE PARTICIPANTS. 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

    THE PURPOSE OF THE ARTICLE WAS TO PRESENT THE RESULTS OF PATIENTS TREATED WITH THE LEO+ BABY, THE ECHELON 10 MICROCATHETER WAS USED IN SOME CASES.   A TOTAL OF 81 PATIENTS WERE INCLUDED (55 FEMALE, 26 MALE, AVERAGE AGE OF 58 YEAR OLD) AND LEO+ BABY DEPLOYMENT WAS SUCCESSFUL IN ALL CASES. COILS WERE USED IN 80 CASES. IN 1 CASE 2 STENTS WERE USED STENT-IN-STENT WITHOUT ADDITIONAL COILING. INITIAL ANEURYSM OCCLUSION RATES WERE MRRCI1 51.9%, MRRCI2 11.1%, MRRCI3A 24.7% AND MRRCI3B 12.3%. OCCLUSION RATES AFTER 6 MONTHS WERE MRRC6M1 78.9%, MRRC6M2 3.9%, MRRC6M3A 6.6% AND MRRC6M3B 10.5%. PROCEDURE-RELATED MORBIDITY WAS 1 CASE OF ACUTE STENT THROMBOSIS SUCCESSFULLY TREATED WITH TIROFIBAN AND 1 CASE WITH TRANSIENT HEMIPARESIS DUE TO STENT THROMBOSIS AFTER 4 MONTHS. THERE WAS 1 CASE OF COIL-ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) WHICH CAUSED PROLONGED HOSPITALIZATION. NO PROCEDURE-RELATED MORTALITY WAS OBSERVED.   THE RESULTS CONFIRM THAT STENT-ASSISTED COILING WITH THE LEO+ BABY STENT IS SAFE AND EFFICIENT FOR TREATMENT OF WIDE NECK OR RECURRENT CEREBRAL ANEURYSMS. SPONTANEOUS PROGRESSIVE ANEURYSM OCCLUSION OVER 6 MONTHS SUPPORTS THE THEORY OF CONSIDERABLE FLOW-MODULATING EFFECTS OF LEO+ BABY.   THERE WERE NO DEVICE ISSUES REPORTED RELATING TO THE USE OF THE ECHELON MICOCATHETER. ADVERSE EVENTS INCLUDED: 1. DELAYED STENT THROMBOSIS 2. SYMPTOMATIC LESIONS 3. ENDOTHELIAL HYPERPLASIA 4. TRANSIENT HEMIPARESIS 5. SUBARACHNOID HEMORRHAGE (PROLONGED HOSPITALIZATION)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058008 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other| H