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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-1040-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis (2100); Patient Problem/Medical Problem (2688)
Event Date 10/29/2019
Event Type  Death  
Manufacturer Narrative
The product in complaint was not returned to the manufacturer for analysis, therefore, a root cause could not be determined.Complaints will continue to be monitored for any trends.
 
Event Description
It was reported that an asymptomatic (b)(6) male patient underwent a right transcarotid revascularization procedure on (b)(6) 2019.It was noted that there was significant calcium in the internal carotid artery (ica).Carotid endarterectomy (cea) and transfemoral carotid artery stenting (tf-cas) were not an option for this patient.The physician crossed the lesion and pre dilated with a 5x30 balloon.A stent was placed.The patient woke up neuro intact, but presented with a stroke throughout the night.A follow up ct was performed which showed that the stent was crimped and thrombosed.An embolectomy was performed.Patient expired three days post tcar procedure.No additional details were provided.
 
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Brand Name
ENROUTE TRANSCAROTID STENT SYSTEM
Type of Device
ENROUTE SDS
Manufacturer (Section D)
SILK ROAD MEDICAL, INC.
1213 innsbruck dr.
sunnyvale CA 94089
Manufacturer (Section G)
SILK ROAD MEDICAL, INC.
1213 innsbruck drive
sunnyvale CA 94089
Manufacturer Contact
1213 innsbruck dr.
sunnyvale, CA 94089
MDR Report Key9373400
MDR Text Key167951782
Report Number3014526664-2019-00081
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020539
UDI-Public(01)00811311020539(17)210331(10)17858027
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 11/25/2019
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 Date03/31/2021
Device Model NumberSR-1040-CS
Device Catalogue NumberSR-1040-CS
Device Lot Number17858027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2019
Initial Date FDA Received11/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2019
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) Death; Required Intervention;
Patient Age75 YR
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