BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID STENT SYSTEM

    MDR report key: 10718795 · Received October 22, 2020

    Report

    Report Number
    3014526664-2020-00097
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 22, 2020
    Report Date
    January 28, 2021
    Manufacturer
    SILK ROAD MEDICAL INC.
    Product Code
    NIM
    UDI-DI
    00811311020461
    PMA / PMN Number
    P140026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION REPORT WAS RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: THE SCANNING ELECTRON MICROSCOPE (SEM) RESULTS SHOWED THE SEPARATED STRUT AREA OF THE STENT UNIT PRESENTED CONSISTENT EVIDENCE OF FATIGUE FRACTURE ON THE STRUTS' SEPARATED SURFACE AREAS. ALSO, NON-METALLIC INCLUSIONS WERE OBSERVED NEAR TO THE FRACTURE ORIGINS. IT IS ASSUMED THAT THE OBSERVED NON-METALLIC INCLUSIONS LED TO FATIGUE CRACK INITIATION, RESULTING ULTIMATELY IN THE SEPARATION OF THE STRUTS' MATERIAL. THE INCLUSIONS OF THE OBSERVED SIZE ARE EXPECTED TO BE FOUND IN THE MATERIAL AND ARE NOT UNCOMMON. FATIGUE FRACTURES IN THIS MATERIAL ARE COMMONLY OBSERVED TO ORIGINATE AT INCLUSIONS SUCH AS THESE. BASED ON LITERATURE REVIEW ON CAROTID STENT FRACTURE, IT IS STATED THAT THE INCIDENCE RATE OF FRACTURES IN SELF EXPANDING CAROTID STENTS IS COMMONLY REPORTED TO BE 6% OR LESS, AND FRACTURES HAVE GENERALLY NOT BEEN ASSOCIATED WITH ADVERSE CLINICAL SEQUELAE. RESEARCHERS HAVE OBSERVED THAT THE CAUSES OF CAROTID STENT FRACTURE ARE MULTIVARIATE, INVOLVING DESIGN ASPECTS OF THE SPECIFIC STENTS, BIOMECHANICAL FACTORS RELATED TO BLOOD FLOW, SWALLOWING, AND MOBILITY OF THE NECK, AND THE PATIENT SPECIFIC NATURE OF THE DISEASE STATE ITSELF, PARTICULARLY CALCIFICATION IN THE REGION STENT IMPLANTATION. FATIGUE PERFORMANCE OF NITINOL COMPONENTS IS UNDERSTOOD TO BE INFLUENCED BY IMPURITIES IN THE MATERIAL, AS WELL AS LOCALIZED CONCENTRATION OF STRESS AND STRAIN IN THE MATERIAL RELATED TO UNIQUE DESIGN ATTRIBUTES OF EACH COMPONENT, AS WELL AS BIOMECHANICAL FORCES AND DEFORMATIONS THAT ARE UNIQUE TO EACH ANATOMICAL REGION OF THE BODY, AND TO SOME EXTENT TO EACH INDIVIDUAL PATIENT. PLEASE SEE THE EM-020414-A-20210115A LITERATURE REVIEW, SEM TECHNICAL RESULTS, AND PRODUCT EVALUATION REPORT ATTACHED UNDER FILE ATTACHMENTS.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION REPORT WAS RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: SEVEN SURFACES WITH FIVE UNIQUE FRACTURES WERE INVESTIGATED AND ALL ANALYZED FRACTURES FROM THE STENT WERE DETERMINED TO BE RELATED TO FATIGUE FAILURE OCCURRING AT THE JUNCTION OF A BRIDGE AND STRUT APEX. ADDITIONAL DEVICE INVESTIGATION IS UNDERWAY AND A FOLLOW-UP MDR WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS MADE AVAILABLE.

    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

    AN ASYMPTOMATIC PATIENT SUCCESSFULLY RECEIVED A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE IN (B)(6) 2020 WITH NO REPORTED ISSUES. A ROUTINE ULTRASOUND PERFORMED ON (B)(6) 2020 REVEALED THAT THE PATIENT HAD ELEVATED VELOCITIES. IN (B)(6) 2020, IT WAS DETERMINED THAT THE STENTS INTEGRITY WAS UNCERTAIN AND THE PHYSICIAN RECOMMENDED TO EXPLANT THE STENT. THE STENT INTEGRITY WAS COMPROMISED UPON STENT EXPLANT. THE PATIENT REMAINED ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184561 ENROUTE TRANSCAROTID STENT SYSTEM ENROUTE SDS NIM SILK ROAD MEDICAL INC. SR-0830-CS 17858025 00811311020461

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention