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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 SDS

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SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE SDS Back to Search Results
Model Number SR-0840-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 08/11/2020
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 lead to the adverse event reported.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of related events.
 
Event Description
It was reported that a patient who received a transcarotid artery revascularization (tcar) procedure had a stent thrombosed and the stent was explanted.The patient has received multiple carotid endarterectomy (cea) procedures and had mixed plaque lesion.The physician stated that there was no intra-operative dissection or clotting noted.The stent was placed under multiple views with pre-dilatation.The patient was on the correct dual antiplatelet therapy (dapt) medication and post-operative blood pressure was appropriately managed.The physician did not note any dissection or carotid artery damage during explantation.There was no negative neurological change from patient after the procedure and the patient did not receive plavix resistance sensitivity testing before or after the procedure.
 
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Brand Name
ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
ENROUTE SDS
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
4087309002
MDR Report Key10521670
MDR Text Key206527726
Report Number3014526664-2020-00082
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020478
UDI-Public(01)00811311020478(17)210930(10)017904658
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 09/11/2020
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 Date09/30/2021
Device Model NumberSR-0840-CS
Device Catalogue NumberSR-0840-CS
Device Lot Number17904658
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2020
Initial Date FDA Received09/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2019
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 Age80 YR
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