BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON

    MDR report key: 23030736 · Received September 11, 2025

    Report

    Report Number
    2029214-2025-02004
    Event Type
    Death
    Date Received
    September 11, 2025
    Date of Event
    October 17, 2024
    Report Date
    September 11, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: PAN, S., CAO, Y., ZHOU, C., JIA, Z., ZHAO, L., SHI, H., LIU, S.. THE PREDICTIVE FACTORS FOR IN-STENT RESTENOSIS AFTER INTERVENTIONAL TREATMENT OF CHRONIC CAROTID ARTERY OCCLUSION. ACTA RADIOLOGICA 66(3) 256-263 2025. DOI: 10.1177/02841851241301114 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. NOTE THAT THE PATIENT INFORMATION (AGE, SEX) IS REFLECTIVE OF THE MEAN OF THE PATIENT DATA IN THE ARTICLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE PREDICTIVE FACTORS FOR IN-STENT RESTENOSIS AFTER INTERVENTIONAL TREATMENT OF CHRONIC CAROTID ARTERY OCCLUSION. MULTIPLE MANUFACTURER'S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ECHELON MICROCATHETER DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE CAUSES OF DEATH WERE SIGNIFICANT REPERFUSION BLEEDING. AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: ONE ELDERLY PATIENT DIED FROM SIGNIFICANT REPERFUSION BLEEDING 1 DAY POSTOPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2706518 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death| R