BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 12032440 · Received June 21, 2021

    Report

    Report Number
    3014526664-2021-00096
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 23, 2021
    Report Date
    August 9, 2021
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NIM
    UDI-DI
    00811311020539
    PMA / PMN Number
    P140026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REPORT OF THIS EVENT AND THE MALFUNCTIONING DEVICE WERE PROVIDED TO SILK ROAD MEDICAL AS THE MANUFACTURER OF THE TRANSCAROTID STENT SYSTEM. AN INVESTIGATION OF THE DEVICE WAS CONDUCTED. BASED ON THE INVESTIGATION, SILK ROAD MEDICAL BELIEVES THAT THE TIP DETACHMENT OF THE DEVICE ASSOCIATED WITH THE EVENT WAS NOT RELATED TO THE MANUFACTURING PROCESS, AND THEREFORE, NOT THE SAME ISSUE ASSOCIATED WITH THE DEVICES SUBJECT TO RECALL. SILK ROAD MEDICAL'S CONCLUSION IS THAT IT IS MORE THAN LIKELY THAT THE DEVICE ASSOCIATED WITH THE EVENT WAS EXPOSED TO FORCES GREATER THAN THE DEVICE WAS DESIGNED TO WITHSTAND, POSSIBLY EXACERBATED BY THE PATIENT CONDITION OR MEDICAL PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, AFTER STENT DEPLOYMENT, THE STENT DELIVERY NOSECONE CATHETER TIP FELL OFF INSIDE THE SHEATH UPON REMOVAL. USING FLUOROSCOPY, THE TIP WAS VISUALIZED IN THE MOST PROXIMAL PORTION OF THE SHEATH. THE SHEATH WAS REMOVED AND FLUSHED, AND THE CATHETER TIP CAME OUT IN ONE COMPLETE PIECE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM OR ADVERSE CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, INVESTIGATION OF THE DEVICE IS STILL IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE 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 TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, AFTER STENT DEPLOYMENT, THE STENT DELIVERY NOSECONE CATHETER TIP FELL OFF INSIDE THE SHEATH UPON REMOVAL. USING FLUOROSCOPY, THE TIP WAS VISUALIZED IN THE MOST PROXIMAL PORTION OF THE SHEATH. THE SHEATH WAS REMOVED AND FLUSHED, AND THE CATHETER TIP CAME OUT IN ONE COMPLETE PIECE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928438 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE TSS NIM SILK ROAD MEDICAL INC. SR-1040-CS 301617 00811311020539

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention