BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 8875936 · Received August 8, 2019

    Report

    Report Number
    3014526664-2019-00056
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 8, 2019
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311020829
    PMA / PMN Number
    K153485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN COMPLAINT WAS RETURNED TO SILK ROAD MEDICAL, INC. ON 17JUL2019. A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED AND IT WAS OBSERVED THAT THE VENOUS SHEATH BODY WAS SEPARATED AT TWO LOCATIONS (AT APPROXIMATELY 70MM AND 80MM FROM THE SHEATH TIP) WITH THE FLAT SS WIRE ATTACHED BUT UNCOILED. THE PROXIMAL SIDE OF THE SHEATH WAS STILL CONNECTED TO THE Y-ADAPTER AND THE SHEATH BODY WAS DEFORMED BY STRETCHING. THE DISTAL PORTION OF THE SHEATH HAD 3 DEFORMED MARKS, MOST LIKELY FROM A HEMOSTAT CLAMPING TOOL USED IN RETRIEVAL EFFORTS. BOTH LOCATIONS WHERE SEPARATION OCCURRED ALSO EXHIBITED SIGNS OF DEFORMATION CAUSED BY HEMOSTAT CLAMPING, CONSISTENT WITH THE OTHER LOCATIONS. MULTIPLE HEMOSTAT MARKS ON THE SHEATH INDICATES THAT SOMETHING MADE IT DIFFICULT TO REMOVE THE SHEATH FROM THE FEMORAL VEIN AND THE SEPARATION OF THE SHEATH BODY WAS MOST LIKELY DUE TO A COMBINATION OF HEMOSTAT CLAMPING UNUSUALLY HIGH TENSION FORCES ON THE SHEATH DURING EFFORTS TO RETRIEVE IT FROM THE PATIENT'S FEMORAL VEIN. THIS IS ALSO CONSISTENT WITH THE ACCOUNT BY THE SR. THERAPY DEVELOPMENT SPECIALIST WHO WAS PRESENT DURING THE PROCEDURE. THE PHYSICIAN STATED HE BELIEVES THE REASON THE SHEATH GOT SNAGGED WAS LARGELY DUE TO THE AMOUNT OF SCAR TISSUE IN THE AREA DUE TO PREVIOUS SURGERIES. THE PATIENT HAD 3 PREVIOUS SURGERIES WITH BI-LATERAL STENTS HOWEVER IT IS NOT BELIEVED THAT THE VENOUS SHEATH INTERACTED WITH ANY EXISTING STENTS. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. IN SUMMARY AND REVIEW OF THE RETURNED DEVICE, THERE IS NO INDICATION THAT ANY PART OF THE DEVICE FAILED TO MEET SPECIFICATIONS OR HAD MANUFACTURING DEFECTS THAT COULD HAVE CONTRIBUTED TO THE SHEATH BEING CAUGHT IN THE PATIENT'S FEMORAL VEIN OR CONTRIBUTED TO SHEATH SEPARATION. MULTIPLE HEMOSTAT MARKS ON THE SHEATH INDICATES THAT SOMETHING MADE IT DIFFICULT TO REMOVE THE SHEATH FROM THE FEMORAL VEIN AND THE SEPARATION OF THE SHEATH BODY WAS MOST LIKELY DUE TO UNUSUALLY HIGH TENSION FORCES ON THE SHEATH DURING EFFORTS TO RETRIEVE IT FROM THE PATIENT'S FEMORAL VEIN. THE EVIDENCE IS CONSISTENT WITH THE PHYSICIAN'S ASSESSMENT THE SHEATH WAS GRIPPED /SNAGGED BY THE ATYPICAL ANATOMY OF THE PATIENT DUE TO AMOUNT OF SCAR TISSUE FROM PREVIOUS SURGERIES. THE DEVICE MET ALL OF THE REQUIRED IN-PROCESS/VERIFICATION ACCEPTANCE CRITERIA. SILK ROAD MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR OCCURRENCES WHERE THE SHEATH CANNOT BE REMOVED EASILY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PLACEMENT OF THE FEMORAL SHEATH ON (B)(6) 2019, THE SURGICAL TEAM ENCOUNTERED SOME RESISTANCE FROM PRIOR FEMORAL ACCESS SURGERIES. A 4, 6 AND 10 FRENCH DILATOR WERE ALL USED. THE SILK ROAD 8 FRENCH FEMORAL SHEATH WAS PLACED. THE SURGERY CONTINUED AND THE STENT WAS PLACED WITHOUT INCIDENCE. DURING THE REMOVAL OF THE 8 FRENCH FEMORAL SHEATH, THE SHEATH BROKE IN THE MIDDLE AND A PIECE REMAINED IN THE VESSEL AFTER GETTING SNAGGED. AFTER RE-ACCESSING THE VESSEL, THE SURGICAL TEAM WAS ABLE TO REMOVE THE BROKEN PORTIONS OF THE SHEATH AND CLOSE THE VESSEL. THE PATIENT'S LEG WAS THEN CLOSED AND THE PATIENT RETURNED TO BASELINE. THE DOCTOR BELIEVED THE REASON THAT THE SHEATH GOT CAUGHT WAS LARGELY DUE TO THE AMOUNT OF SCAR TISSUE IN THE AREA, AS A RESULT OF THE PATIENT'S PREVIOUS SURGERIES. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670666 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM ENROUTE NPS NTE SILK ROAD MEDICAL SR-200-NPS 300395 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention