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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-1040-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Event Date 05/07/2022
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.There is no indication that a malfunction of the srm device occurred; the cause of the post-operative complication is unknown, therefore, the complaint will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.A supplemental mdr will be submitted if additional information is received.
 
Event Description
It was reported that a patient who received a transcarotid artery revascularization (tcar) procedure on (b)(6) 2022 returned to the emergency room on (b)(6) 2022 after experiencing stroke-like symptoms.Imaging revealed that the stent had thrombosed.The physician elected to perform an aspiration thrombectomy and implanted two stents to resolve the thrombosis.Patient was reported to be neurologically intact.At this time, there is no indications as to what may have caused the thrombus as the stent was not compromised and was fully expanded.There were no blood pressure issues noted.The patient was reported to be compliant with dual antiplatelet therapy, and plavix testing revealed no issues.Therefore, this event will be reported out of abundance of caution.
 
Manufacturer Narrative
Based on the information provided, a follow-up mdr is being submitted to remove the following fields: clinical code 4418 "ischemia stroke" under section h6: health effect - clinical code.The patient experienced a transient ischemic attack (tia), which does not meet the clinical definition of a stroke.Clinical code 4618 "permanent impairment" under section h6: health effect - impact code is being removed as the patient was reported to be neurologically intact post procedure.Outcomes attributed to adverse event: removed disability or permanent damage as the patient was reported to be neurologically intact post procedure.
 
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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 Key14552190
MDR Text Key293077268
Report Number3014526664-2022-00074
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020539
UDI-Public(01)00811311020539(17)240831(10)18055275
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 09/02/2022
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-1040-CS
Device Catalogue NumberSR-1040-CS
Device Lot Number18055275
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/08/2022
Initial Date FDA Received05/31/2022
Supplement Dates Manufacturer Received05/08/2022
Supplement Dates FDA Received09/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2021
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; Disability;
Patient Age78 YR
Patient SexFemale
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