BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER FX

    MDR report key: 8052116 · Received November 8, 2018

    Report

    Report Number
    2183870-2018-00506
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    August 22, 2018
    Report Date
    November 8, 2018
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUBLISHED DATE CAROTID ARTERY STENTING WITH PROXIMAL EMBOLIC PROTECTION VIA THE TRANSBRACHIAL APPROACH: SHEATHLESS NAVIGATION OF A 9-F BALLOON-GUIDING CATHETER NEURORADIOLOGY (2018) 60:1097¿1101 HTTPS://DOI.ORG/10.1007/S00234-018-2085-2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A TRANSBRACHIAL CAS TECHNIQUE WITH PROXIMAL PROTECTION BY SHEATHLESS NAVIGATION OF A 9-F BALLOON-GUIDING CATHETER WITH AN OUTER DIAMETER EQUIVALENT TO A 7-F SHEATH WAS PERFORMED IN 8 CONSECUTIVE PATIENTS AMONG 39 PATIENTS WHO UNDERWENT CAS FROM APRIL 2016 TO JUNE 2017. MEDTRONIC DEVICES SUCH AS CAROTID GUARDWIRE AND SPIDER FX WERE USED DURING THE PROCEDURE. TECHNICAL SUCCESS WAS ACCOMPLISHED IN ALL PATIENTS. ONE PATIENT WHO HAD TREATMENT ON THE RIGHT SIDE TO TREAT 58% CAROTID STENOSIS WITH A TYPE 3 AORTIC ARCH EXPERIENCED A THROMBOEMBOLIC EVENT DUE TO KINKING OF THE GUIDING CATHETER. THE COMMON CAROTID ARTERY (CCA) TAKEOFF ANGLE IS REPORTED AS 30 DEGREES. NO NEW NEUROLOGICAL DEFICITS WERE OBSERVED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889515 SPIDER FX NTE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention