BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 18130614 · Received November 14, 2023

    Report

    Report Number
    2029214-2023-02206
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    July 10, 2023
    Report Date
    November 14, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-ONYX (UNKNOWN). PRODUCT ID: UNK-NV-MARATHON (UNKNOWN). G2: CITATION: AUTHORS: ZHANG B, QI J, CHEN P, ET AL. DELIBERATELY STAGED COMBINED ENDOVASCULAR EMBOLIZATION AND SUBSEQUENT MICROSURGERY RESECTION FOR THE TREATMENT OF CEREBRAL ARTERIOVENOUS MALFORMATIONS. WORLD NEUROSURGERY 178:E254-E264 2023. DOI:10.1016/J.WNEU.2023.07.040. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    ZHANG, B., QI, J., CHEN, P., SUN, B., LING, Y., WU, Q., XU, S., WU, P., & SHI, H. (2023). DELIBERATELY STAGED COMBINED ENDOVASCULAR EMBOLIZATION AND SUBSEQUENT MICROSURGERY RESECTION FOR THE TREATMENT OF CEREBRAL ARTERIOVENOUS MALFORMATIONS. WORLD NEUROSURGERY, 178, E254¿E264. HTTPS://DOI.ORG/10.1016/J.WNEU.2023.07.040. MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF SUBARACHNOID HEMORRHAGE, CEREBRAL INFARCTION, INTRACRANIAL INFECTION, EPILEPSY, RIGHT HAND HEMIPLEGIA, AND VISUAL FIELD DEFICITS IN ASSOCIATION WITH MARATHON CATHETER, ECHELON CATHETER, AND ONYX USE IN ENDOVASCULAR EMBOLIZATION. THE RESEARCH SUPPORTED GOOD SAFETY AND EFFICACY FOR THE AVM TREATMENT USED. THE PURPOSE OF THIS ARTICLE WAS TO DETERMINE THE EFFICACY IN ENDOVASCULAR EMBOLIZATION AND MICROSURGERY RESECTION OF ARTERIOVENOUS MALFORMATIONS. THE AUTHORS REVIEWED 30 CASES OF PATIENTS TREATED FOR RUPTURED OR NON-RUPTURED CEREBRAL ARTERIOVENOUS MALFORMATIONS USING A MARATHON CATHETER, ECHELON CATHETER, AND ONYX IN AN ENDOVASCULAR EMBOLIZATION. OF THE 30 PATIENTS, THE AVERAGE AGE WAS 37 YEARS, 12 WERE FEMALE AND 18 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF ONYX. THERE WAS HOWEVER, A MICROCATHETER PERFORATION WITH A MICROCATHETER; IT WAS NOT SPECIFIED WHETHER IT WAS THE MARATHON OR ECHELON CATHETER. IN ADDITION, 26 PATIENTS HAD MRS SCORE OF 0-2 AT FOLLOW UP. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. SUBARACHNOID HEMORRHAGE INCLUDING DUE TO MICROCATHETER PERFORATION. 2. CEREBRAL INFARCTION. 3. INTRACRANIAL INFECTION. 4. EPILEPSY. 5. NEW FOCAL NEUROLOGICAL DEFICITS: 5A. RIGHT HAND HEMIPLEGIA; 5B. VISUAL FIELD DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926860 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10...