BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 10674067 · Received October 13, 2020

    Report

    Report Number
    3014526664-2020-00091
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 14, 2020
    Report Date
    October 13, 2020
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NIM
    UDI-DI
    00811311020492
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DISTAL TIP WAS NOT RETURNED FOR ANALYSIS. NEVERTHELESS, PER MICROSCOPIC ANALYSIS, SCANNING ELECTRON MICROSCOPY (SEM) TESTS RESULTS SHOWED THAT THE SEPARATED AREA OF THE INNER SHAFT OF THE UNIT PRESENTED EVIDENCE OF ELONGATIONS AND CUP AND CONE SHAPE-LIKE. BRAID WIRES ON THE INNER SHAFT PRESENTED EVIDENCE OF PLASTIC DEFORMATION, DIAMETER REDUCTION AND DUCTILE DIMPLES ON THEIR SURFACE. THE PREVIOUSLY MENTIONED DAMAGES ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THE CAUSE OF THE MATERIAL SEPARATION OBSERVED ON THE INNER SHAFT, THE BENT CONDITION OF THE BODY/SHAFT OF THE CATHETER, AND THE PARTIAL DEPLOYMENT OF THE STENT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. THE REPORTED FAILURE IS NOT RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. A REVIEW OF MANUFACTURING RECORDS FOR THIS DEVICE WAS COMPLETED AND NO ISSUES WERE IDENTIFIED THAT COULD HAVE LED TO THE ADVERSE EVENT REPORTED A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. SILK ROAD MEDICAL WILL CONTINUE TO MONITOR FOR OCCURRENCES OF SIMILAR EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANS-CAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE STENT WOULD NOT PASS THROUGH THE LESION. WHILE PULLING THE STENT BACK, THE DISTAL TIP OF THE STENT DELIVERY SYSTEM CAME OFF, AND REMAINED IN THE CAROTID ARTERY. THE PHYSICIAN MADE THE DECISION TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA), AND SUCCESSFULLY REMOVED THE MARKER, AND THE CAROTID WAS FIXED. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137658 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE SDS NIM SILK ROAD MEDICAL INC. SR-0930-CS 17917092 00811311020492

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention