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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 Problems Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Event Date 10/19/2022
Event Type  Injury  
Event Description
It was reported that 7 hours after a right transcarotid artery revascularization (tcar) procedure, the patient had a thrombotic stroke and left arm and leg weakness with slight facial droop.Thrombus was found distal to the stent, which was treated with thrombectomy, but the patient still had left arm and leg weakness and slight facial droop.The physician also switched the patient's medication to brilinta at the onset of stroke symptoms; however there was no conclusive evidence provided that the patient was plavix resistant.At this time, there is no conclusive evidence if the patient was plavix resistant.As this event could be associated with the enroute transcarotid stent system (tss), it will be reported out of abundance of caution.
 
Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.A review of manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.There is no indication that a malfunction of the srm device occurred.The cause of the post-operative complication is unknown.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
 
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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 1317
Manufacturer (Section G)
SILK ROAD MEDICAL INC
1213 innsbruck drive
sunnyvale CA 94089 1317
Manufacturer Contact
jasneet bedi
1213 innsbruck drive
sunnyvale, CA 94089-1317
4087209002
MDR Report Key15785269
MDR Text Key303552729
Report Number3014526664-2022-00172
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020508
UDI-Public(01)00811311020508(17)250331(10)18104104
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 11/11/2022
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 Model NumberSR-0940-CS
Device Catalogue NumberSR-0940-CS
Device Lot Number18104104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2022
Initial Date FDA Received11/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2022
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; Disability;
Patient Age79 YR
Patient SexFemale
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