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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 Problem Thrombosis/Thrombus (4440)
Event Date 05/10/2022
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 two hours after the completion of a transcarotid artery revascularization (tcar) procedure, the patient's implanted stent had thrombosed.The physician elected to perform a balloon and aspiration thrombectomy to resolve the thrombosis, and the patient was placed on ticagrelor/brilinta.At this time, it is unknown if the reported failure is related to procedural issues, patient resistance to dual antiplatelet therapy (dapt) medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
 
Event Description
It was reported that two hours after the completion of a transcarotid artery revascularization (tcar) procedure, the patient's implanted stent had thrombosed.The physician elected to perform a balloon and aspiration thrombectomy to resolve the thrombosis, and the patient was placed on ticagrelor/brilinta.At this time, it is unknown if the reported failure is related to procedural issues, patient resistance to dual antiplatelet therapy (dapt) medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
 
Manufacturer Narrative
Additional/updated information can be found in the following fields: b4: date of this report.D4: additional device information.G6: type of report.H2: if follow up, what type? a follow-up mdr is being submitted to reflect the correct unique device identifier under section d4: unique identifier (udi) #.
 
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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 Key14593444
MDR Text Key293273572
Report Number3014526664-2022-00075
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020508
UDI-Public(01)00811311020508(17)240131(10)18001563
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 07/11/2022
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 Expiration Date01/31/2024
Device Model NumberSR-0940-CS
Device Catalogue NumberSR-0940-CS
Device Lot Number18001563
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/10/2022
Initial Date FDA Received06/03/2022
Supplement Dates Manufacturer Received05/10/2022
Supplement Dates FDA Received07/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2021
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;
Patient Age72 YR
Patient SexMale
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