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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS

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SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS Back to Search Results
Model Number SR-0940-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 09/29/2021
Event Type  Injury  
Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.Complaints will continue to be reviewed and monitored for trends.
 
Event Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was noticed on the right internal carotid artery after stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.The procedure was completed successfully, and the clinical condition of the patient is noted to be stable.It was noted that the patient's anatomy may have been a contributing factor to the dissection.The physician used multiple wires and catheters to try to cross, however it was not confirmed exactly at which point and what caused the dissection.There were many steps before the physician was even able to take a picture to see what was going on to see that a dissection occurred.Although it is noted that the dissection was caused by the patients difficult anatomy, at this time it is unknown if the stent may have caused or contributed to the dissection event, therefore, this case will be reported out of abundance of caution.
 
Event Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was noticed on the right internal carotid artery after stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.The procedure was completed successfully, and the clinical condition of the patient is noted to be stable.It was noted that the patient's anatomy may have been a contributing factor to the dissection.The physician used multiple wires and catheters to try to cross, however it was not confirmed exactly at which point and what caused the dissection.There were many steps before the physician was even able to take a picture to see what was going on to see that a dissection occurred.Although it is noted that the dissection was caused by the patients difficult anatomy, at this time it is unknown if the stent may have caused or contributed to the dissection event, therefore, this case will be reported out of abundance of caution.
 
Manufacturer Narrative
Additional/updated information can be found in the following fields: b4: date of this report.G6: date received by manufacturer.G6: type of report.H2: if follow up, what type? a follow-up mdr is being submitted to reflect the correct date the information was provided to silk road medical in section g3.
 
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Brand Name
ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
ENROUTE TSS
Manufacturer (Section D)
SILK ROAD MEDICAL INC.
1213 innsbruck drive
sunnyvale CA 94089
Manufacturer (Section G)
SILK ROAD MEDICAL INC.
1213 innsbruck drive
sunnyvale CA 94089
Manufacturer Contact
magaly boardman
1213 innsbruck drive
sunnyvale, CA 94089
4087209002
MDR Report Key12609313
MDR Text Key278190419
Report Number3014526664-2021-00154
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020508
UDI-Public(01)00811311020508(17)240430(10)18023943
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2024
Device Model NumberSR-0940-CS
Device Catalogue NumberSR-0940-CS
Device Lot Number18023943
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/11/2021
Supplement Dates Manufacturer Received09/29/2021
Supplement Dates FDA Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient SexFemale
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