BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC KIT 106CM 40CM TZ

    MDR report key: 11822935 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-05835
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    January 1, 2020
    Report Date
    May 13, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K182324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EVENT DATE WAS NOT REPORTED. THE FIRST DAY OF THE YEAR THE ARTICLE WAS ACCEPTED BY THE PUBLISHER WAS USED AS AN ESTIMATE. RASKIN, ADAM, ET. AL, SINGLE-SESSION THROMBOLYSIS-FREE TREATMENT OF DEEP VEIN THROMBOSIS WITH A NOVEL MECHANICAL THROMBECTOMY DEVICE, JACC 2021, VOL. 3 , NO. 3.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE JOURNAL THAT TREATMENT WAS INEFFECTIVE, REQUIRING ADDITIONAL INTERVENTION. A (B)(6)-YEAR-OLD WHITE WOMAN DEVELOPED LEFT LOWER-EXTREMITY (LE) SWELLING AND PAIN AFTER PROLONGED IMMOBILITY SECONDARY TO HEART FAILURE RELATED COMPLICATIONS. DOPPLER ULTRASOUND REVEALED EXTENSIVE DEEP VEIN THROMBOSIS OF THE LEFT LE. VENOGRAPHY CONFIRMED COMPLETE OCCLUSION OF THE LEFT ILIAC AND FEMORAL VEINS. CATHETER DIRECTED THROMBOLYSIS WITH AN EKOSONIC CATHETER VIA LEFT POPLITEAL VEIN ACCESS WAS PERFORMED. AFTER 24 H OF THROMBOLYSIS, A REPEATED VENOGRAM REVEALED INADEQUATE THROMBUS RESOLUTION, PROMPTING THE DECISION TO PERFORM PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) WITH A NON BOSTON SCIENTIFIC DEVICE, WHICH FULLY RESTORED VENOUS BLOOD FLOW WITHOUT ANY COMPLICATIONS. AFTER SUCCESSFUL THROMBECTOMY, THE PATIENT WAS DISCHARGED ON ORAL ANTICOAGULATION WITH APIXABAN AND WAS SYMPTOM FREE AT 3-MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716200 EKOSONIC KIT 106CM 40CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention