BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK BTK

    MDR report key: 8393644 · Received March 6, 2019

    Report

    Report Number
    9612164-2019-00786
    Event Type
    Injury
    Date Received
    March 6, 2019
    Date of Event
    November 28, 2018
    Report Date
    March 6, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MCW
    PMA / PMN Number
    K061188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE ARTICLE PUBLISHED ONLINE JOURNAL ARTICLE TITLE: PERCUTANEOUS MECHANICAL THROMBOEMBOLECTOMY IN ACUTE LOWER LIMB ISCHEMIA CARDIOVASC INTERVENT RADIOL (2019) 42:178¿185. HTTPS://DOI.ORG/10.1007/S00270-018-2129-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH ACUTE ONSET OF CALF PAIN 6 WEEKS EARLIER AND VERY SHORT WALKING DISTANCE. CLINICAL STAGE RUTHERFORD I. A 6-WEEK-OLD EMBOLUS RIDING ON THE TRIFURCATION WITH OCCLUSION OF BOTH ANTERIOR TIBIAL ORIFICE AS THE PROXIMAL TIBIOPERONEAL TRUNK. ROTATIONAL THROMBECTOMY APPEARED RISKY DUE TO THE CURVED AND SMALL ANATOMY. THE ORIFICE OF THE ANTERIOR TIBIAL ARTERY COULD BE SUCCESSFULLY REOPENED BY USE OF AN ATHERECTOMY CATHETER (SILVERHAWK, MEDTRONIC) BUT AFTER ATHERECTOMY OF THE TIBIOPERONEAL TRUNK, EXTRAVASATION IS VISIBLE. AFTER PROLONGED BALLOON ANGIOPLASTY, THE LEAKAGE WAS SEALED AND PATENCY RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189249 SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY MCW MEDTRONIC IRELAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention