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U.S. Department of Health and Human Services

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

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SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; TSS Back to Search Results
Model Number SR-0840-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Event Date 02/18/2022
Event Type  Injury  
Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.The cause of the post-operative complication is unknown.Investigation is ongoing and results are not yet available.A follow-up mdr will be submitted when additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
 
Event Description
It was reported that the following day after the transcarotid artery revascularization (tcar) procedure, the patient experienced an ischemic stroke.The patient also experienced left-sided weakness, in which symptoms improved but did not fully resolve within 24 hours.Computed tomography angiography (cta) and computed tomography (ct) perfusion scan revealed an occluded right carotid where the stent was located.The patient was placed on an oral anticoagulant and was discharged to acute rehabilitation.Additional information obtained indicated that the stent was ovalized, and thrombosis was noted beyond the ovalized segment.
 
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Brand Name
ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
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
yvonne nguyen
1213 innsbruck drive
sunnyvale, CA 94089
4087209002
MDR Report Key13920954
MDR Text Key288889685
Report Number3014526664-2022-00035
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020478
UDI-Public(01)00811311020478(17)240331(10)18019123
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
Report Date 03/25/2022
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 Date03/31/2024
Device Model NumberSR-0840-CS
Device Catalogue NumberSR-0840-CS
Device Lot Number18019123
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/25/2022
Initial Date FDA Received03/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2021
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) Disability; Required Intervention;
Patient Age66 YR
Patient SexMale
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