BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 17435394 · Received August 1, 2023

    Report

    Report Number
    2029214-2023-01264
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    January 18, 2023
    Report Date
    August 1, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K042187
    Adverse Event
    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-ECHELON. G2: CITATION: AUTHORS: WANG, G., LIU, J., HE, S., ZHANG, X., YANG, L., GAO, F., GUO, Y., & XU, R. (2023).. ADVANCED AGE IS ASSOCIATED WITH INCREASED ADVERSE OUTCOMES IN PATIENTS UNDERGOING MIDDLE CEREBRAL ARTERY STENTING. FRONTIERS IN NEUROLOGY 13:1037034. 2023. DOI:10.3389/FNEUR.2022.1037034 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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

    WANG G, LIU J, HE S, ET AL. ADVANCED AGE IS ASSOCIATED WITH INCREASED ADVERSE OUTCOMES IN PATIENTS UNDERGOING MIDDLE CEREBRAL ARTERY STENTING. FRONTIERS IN NEUROLOGY. 2023;13:1037034. DOI:10.3389/FNEUR.2022.1037034 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THE ECHELON 10 MICROCATHETER. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE WHETHER ADVANCED AGE HAS AN INCREASED INCIDENCE OF MAJOR COMPLICATIONS IN PATIENTS UNDERGOING MIDDLE CEREBRAL ARTERY (MCA) STENTING. A TOTAL OF 348 PATIENTS WHO HAD BEEN TREATED WITH MCA STENTING FROM MARCH 2005 TO JULY 2020 WERE RETROSPECTIVELY ANALYZED. THERE WERE 264 MALES AND 84 FEMALES WITH THE AVERAGE AGE OF 50.6 YEARS. NINETY-DAY ISCHEMIC STROKE, INTRACEREBRAL HEMORRHAGE, AND DEATH OUTCOMES WERE COMPARED AMONG THE YOUNG (=40 YEARS OLD), MIDDLE (41¿60 YEARS OLD) AND OLD (=61 YEARS OLD) GROUPS. AFTER GENERAL ANESTHESIA AND SYSTEMIC HEPARINIZATION, FEMORAL ARTERY PUNCTURE WAS PERFORMED TO PLACE A 6F/8F ARTERIAL SHEATH. A 6F GUIDING CATHETER ENVOY (CERENOVUS) WAS DELIVERED TO THE C2¿3 SEGMENT OF THE INTERNAL CAROTID ARTERY. OVER A SYNCHRO-10 GUIDEWIRE (STRYKER NEUROVASCULAR), AN ECHELON 10 MICROCATHETER (MEDTRONIC NEUROVASCULAR) WAS NAVIGATED TO THE DISTAL PART OF THE STENOSIS. THE SYNCHRO10 GUIDEWIRE WAS THEN RETRIEVED, AND AN EXCHANGEABLE SYNCHRO-14 GUIDEWIRE (STRYKER NEUROVASCULAR) WAS ADVANCED INTO THE ARTERY DISTAL TO THE STENOSIS THROUGH THE MICROCATHETER. THEN, A GATEWAY BALLOON (BOSTON SCIENTIFIC) WAS PLACED ACROSS THE STENOTIC SEGMENT FOR BALLOON DILATATION. THE CHOICE OF STENT TYPE (WINGSPAN OR NEUROFORM EZ) WAS DECIDED BASED ON THE DIAMETER OF THE TARGET ARTERY AND THE SITE OF THE LESION. IF NO ABNORMALITIES WERE OBSERVED, THE STENTING PROCEDURE WAS COMPLETED. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ECHELON 10 CATHETER. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 13 PATIENTS DIED, 16 PATIENTS HAD ISCHEMIC STROKE, 38 PATIENTS HAD INTRACEREBRAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634799 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other SEE H10...