BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 11240261 · Received January 27, 2021

    Report

    Report Number
    3014526664-2021-00010
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 2, 2021
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NIM
    UDI-DI
    00811311020508
    PMA / PMN Number
    P140026
    Removal / Correction Number
    3014526664-1/17/21-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. A PHYSICAL REVIEW OF THE DEVICE WAS CONDUCTED, WHICH DID NOT PROVIDE SUFFICIENT EVIDENCE TO DETERMINE THE CAUSE OF THE FAILURE. BASED ON TESTING CONDUCTED TO DATE, WE BELIEVE THAT THE FAILURE IS RELATED TO A SINGLE OPERATOR THAT PRODUCED LOTS OVER A SPECIFIC TIME PERIOD THAT DID NOT MEET SPECIFICATIONS. THE LOTS MANUFACTURED BY THIS OPERATOR ARE CURRENTLY UNDERGOING CORRECTIVE ACTION AS REPORTS OF OTHER DETACHMENTS WERE RECEIVED. BASED ON THIS INFORMATION, SILK ROAD MEDICAL INITIATED A VOLUNTARY PRODUCT RECALL ON JANUARY 13, 2021, WHICH FURTHER EXPANDED ON JANUARY 24, 2021 AND FEBRUARY 3, 2021. ALL INFORMATION HAS BEEN CAPTURED UNDER CAPA-0211.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, AFTER STENT DEPLOYMENT, THE DISTAL TIP (NOSECONE) WAS DETACHED FROM THE STENT DEPLOYMENT SYSTEM (SDS) AND CAME OFF AT THE HEMOSTASIS VALVE AND WAS RETRIEVED USING FLUOROSCOPY. 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, AFTER STENT DEPLOYMENT, THE DISTAL TIP (NOSECONE) WAS DETACHED FROM THE STENT DEPLOYMENT SYSTEM (SDS) AND CAME OFF AT THE HEMOSTASIS VALVE AND WAS RETRIEVED USING FLUOROSCOPY . A FINAL ANGIOGRAM WAS PERFORMED WITH NO NOTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133613 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE TSS NIM SILK ROAD MEDICAL INC. SR-0940-CS 301576 00811311020508

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR