BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 10118578 · Received June 3, 2020

    Report

    Report Number
    MW5094829
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 1, 2020
    Manufacturer
    SILK ROAD MEDICAL, INC.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE WAS PRESENT FOR A LEFT TRANSCAROTID ARTERY STENT PLACEMENT DUE TO SEVERE ASYMPTOMATIC BILATERAL (LEFT MORE IRREGULAR THAN RIGHT) CAROTID ARTERY STENOSIS. DURING THE PROCEDURE, ANGIOGRAM SHOWED A VERY LONG LESION WITH MID AND DISTAL CCA DISEASE THAT THE SURGEON PLANNED TO COVER. PRE-DILATION WAS PERFORMED WITH A 5 X 20 MM BSC BALLOON. AN 8 X 30 MM ENROUTE STENT WAS THEN PLACED FROM THE MID ICA THROUGH THE DISTAL CCA. A SECOND 8 X 30 MM ENROUTE STENT WAS THEN PLACED JUST OUTSIDE THE SHEATH INTO THE PROXIMAL ICA WITH STANDARD OVERLAP. THIS WAS DEPLOYED IN TYPICAL FASHION, HOWEVER THE STENT DID NOT UNSHEATH. DESPITE THIS, THE SURGEON WAS ABLE TO REMOVE IT OFF THE WIRE. AN 8 X 40 MM ENROUTE STENT WAS THEN PLACED AND DEPLOYED FROM THE PROXIMAL ICA THROUGH THE MID CCA, JUST OUTSIDE OF THE SHEATH TIP. THE REMAINDER OF THE PROCEDURE WAS PERFORMED WITHOUT FURTHER INCIDENT AND THE PATIENT WENT TO THE RECOVERY ROOM IN STABLE CONDITION WITHOUT COMPLICATIONS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578826 ENROUTE TRANSCAROTID STENT SYSTEM STENT, CAROTID NIM SILK ROAD MEDICAL, INC. 17918071

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR