BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 10963523 · Received December 7, 2020

    Report

    Report Number
    3014526664-2020-00123
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 23, 2020
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NIM
    UDI-DI
    00811311020539
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION REPORT WAS RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: THE CATHETER TIP SEPARATED WAS CONFIRMED, HOWEVER THESE DAMAGES ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE INNER WIRE LUMEN SHAFT MATERIAL WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE INNER WIRE LUMEN SHAFT MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. PROCEDURAL FACTORS AND/ OR HANDLING PROCESS MAY HAVE CONTRIBUTED TO THE OBSERVED DAMAGES OF THE UNIT. THE CAUSE OF THE MATERIAL SEPARATION OBSERVED ON THE INNER WIRE LUMEN SHAFT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. THERE IS NO EVIDENCE THAT SUGGESTS THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. 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 · 0

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE STENT DEPLOYMENT SYSTEM TIP MARKER WAS FOUND TO BE MISSING. FLUOROSCOPY WAS ACTIVATED AND THE STENT TIP MARKER WAS ON THE GUIDEWIRE AT THE END OF THE ENROUTE SHEATH. A SNARE WAS INSERTED, AND THE TIP WAS RETRIEVED SUCCESSFULLY WITH NO REPORTED PATIENT HARM OR ADVERSE CONSEQUENCE. A FINAL ANGIOGRAM WAS PERFORMED WITH NO NOTED ISSUES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED, HOWEVER THE INVESTIGATION IS UNDERWAY. A PRELIMINARY REVIEW OF THE 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 ONCE ADDITIONAL INFORMATION IS MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE SENT DEPLOYMENT SYSTEM TIP MARKER WAS FOUND TO BE MISSING. FLUOROSCOPY WAS ACTIVATED AND THE STENT TIP MARKER WAS ON THE GUIDEWIRE AT THE END OF THE ENROUTE SHEATH. A SNARE WAS INSERTED, AND THE TIP WAS RETRIEVED SUCCESSFULLY WITH NO REPORTED PATIENT HARM OR ADVERSE CONSEQUENCE. A FINAL ANGIOGRAM WAS PERFORMED WITH NO NOTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427925 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE SDS NIM SILK ROAD MEDICAL INC. SR-1040-CS 17931107 00811311020539

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention