BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 13529551 · Received February 14, 2022

    Report

    Report Number
    2029214-2022-00220
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    December 6, 2020
    Report Date
    February 14, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UFLACKER A, HASKAL ZJ, PATRIE J, ET AL. IMPROVING CONE-BEAM CT ANGIOGRAPHY FOR PROSTATIC ARTERY EMBOLIZATION: IS A LOW-DOSE PROTOCOL EQUIVALENT TO THE STANDARD? JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY. 2021;32(4):562-568. DOI:10.1016/J.JVIR.2020.12.016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    UFLACKER A, HASKAL ZJ, PATRIE J, ET AL. IMPROVING CONE-BEAM CT ANGIOGRAPHY FOR PROSTATIC ARTERY EMBOLIZATION: IS A LOW-DOSE PROTOCOL EQUIVALENT TO THE STANDARD? JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY. 2021;32(4):562-568. DOI:10.1016/J.JVIR.2020.12.016. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH AN ECHELON MICROCATHETER. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE THE UTILITY OF LOW-DOSE VERSUS STANDARD CONE-BEAM COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY PROTOCOLS IN IDENTIFYING NONTARGET EMBOLIZATION (NTE) DURING PROSTATIC ARTERY EMBOLIZATION (PAE). TWENTY-ONE PATIENTS WERE INCLUDED, AND THE MEAN AGE WAS 69.6 YEARS. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ECHELON MICROCATHETER. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: THERE WAS ONE MAJOR ADVERSE EVENT, WHICH WAS A CASE OF HYDRONEPHROSIS TREATED WITH URETERAL STENTS, WHICH RESOLVED WITHIN 3 MONTHS OF PLACEMENT. THIS MAJOR ADVERSE EVENT WAS DETERMINED TO BE LIKELY RELATED TO THE PROCEDURE, BUT NO OBVIOUS SOURCE OF NTE COULD BE IDENTIFIED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585590 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention