BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON

    MDR report key: 11555346 · Received March 23, 2021

    Report

    Report Number
    2029214-2021-00330
    Event Type
    Death
    Date Received
    March 23, 2021
    Date of Event
    December 1, 2020
    Report Date
    March 23, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    F. GAO, X. SUN, X. GUO, D. LI, G.D. XU AND Z.R. MIAO. OPEN ACCESS ENDOVASCULAR RECANALIZATION OF SYMPTOMATIC NONACUTE INTRACRANIAL I NTERNAL CAROTID ARTERY OCCLUSION: PROPOSAL OF A NEW ANGIOGRAPHIC CLASSIFICATION AMERICAN JOURNAL OF NEURORADIOLOGY FEBRUARY 2021, 42 (2) 299-305; DOI.ORG/10.3174/AJNR.A6928 THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    F. GAO, X. SUN, X. GUO, D. LI, G.D. XU AND Z.R. MIAO. OPEN ACCESS ENDOVASCULAR RECANALIZATION OF SYMPTOMATIC NONACUTE INTRACRANIAL I NTERNAL CAROTID ARTERY OCCLUSION: PROPOSAL OF A NEW ANGIOGRAPHIC CLASSIFICATION AMERICAN JOURNAL OF NEURORADIOLOGY FEBRUARY 2021, 42 (2) 299-305; DOI.ORG/10.3174/AJNR.A6928 MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO REPORT MULTICENTER CLINICAL RESULTS OF ENDOVASCULAR RECANALIZATION FOR MEDICALLY REFRACTORY, NONACUTE, INTRACRANIAL ICA OCCLUSION AND TO PROPOSE A NEW ANGIOGRAPHIC CLASSIFICATION TO EXPLORE WHICH SUBGROUPS OF PATIENTS ARE MOST AMENABLE TO THIS TREATMENT. THE AUTHORS REVIEWED 36 CASES OF PATIENTS TREATED FOR ENDOVASCULAR RECANALIZATION FOR REFRACTORY, NONACUTE, ATHEROSCLEROTIC INTRACRANIAL ICA OCCLUSION USING EITHER AN ECHELON MICROCATHETER OR A NON-MEDTRONIC CATHETER IN CONJUNCTION WITH OTHER NON-MEDTRONIC PRODUCTS FOR A THROMBECTOMY. OF THE 36 PATIENTS, THE AVERAGE AGE WAS 54 YEARS, 12 WERE FEMALE AND 24 WERE MALE. IF THE ATTEMPTS WERE REPEATED AND THE MICROWIRE AND MICROCATHETER COULD NOT PASS THE OCCLUDED SEGMENT AND ENTER THE DISTAL TRUE LUMEN, THE PROCEDURE WAS STOPPED. IF THE MICROWIRE WAS SUCCESSFULLY STEERED THROUGH THE OCCLUDED SEGMENT, THEN MICROCATHETER INJECTION CONFIRMED THE POSITION DISTAL TO OCCLUSION IN THE DISTAL TRUE LUMEN. THE OVERALLTECHNICAL SUCCESS RATE WAS 80.6% (29/36). THE CLINICAL SYMPTOMS OF THE PATIENTS IN THIS GROUP WERE RELATIVELY MILD THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. TWO PATIENTS HAD REPERFUSION HEMORRHAGE 3 AND 4 HOURS AFTER SUCCESSFUL RECANALIZATION; THEIR SYMPTOMS DETERIORATED RAPIDLY, AND THEY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450066 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| L