BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET

    MDR report key: 10079116 · Received May 21, 2020

    Report

    Report Number
    2134265-2020-06798
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    February 1, 2020
    Report Date
    May 21, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VEENSTRA, E. B., VAN DER LAAN, M. J, ET AL. (2020). A SYSTEMATIC REVIEW AND META-ANALYSIS OF ENDOVASCULAR AND SURGICAL REVASCULARIZATION TECHNIQUES IN ACUTE LIMB ISCHEMIA. JOURNAL OF VASCULAR SURGERY, VOLUME 71 (ISSUE 2), PP. 654-668.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT A MAJOR VASCULAR EVENT OCCURRED. META-ANALYSIS SHOWED FAVORING OF LIMB SALVAGE, MEANING THE AVOIDANCE OF ABOVE KNEE OR BELOW-KNEE AMPUTATION OF THE LOWER LIMB, WITH ANGIOJET AT THE 30-DAY, 6-MONTH, AND 1-YEAR FOLLOW-UPS. THERE WAS ONE REPORTED MAJOR VASCULAR EVENT (MVE). MVE WAS DEFINED AS THE OCCURRENCE OF MAJOR HEMORRHAGE NEEDING BLOOD TRANSFUSION OR SURGICAL OR ENDOVASCULAR INTERVENTION, AND HEMORRHAGIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543740 ANGIOJET CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention