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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-0940-CS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Event Date 03/17/2021
Event Type  Injury  
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.Although 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.A secondary mdr was reported under 3014526664-2021-00045 (b)(4) as it is unknown which stent may have caused the customer reported issue.
 
Event Description
It was reported that 13 days after the completion of a transcarotid artery revascularization (tcar) procedure, the patient was re-admitted to the emergency department due to neck hematoma and arm weakness.An angiogram was performed and showed partial stent thrombosis.The patient was referred to a local vascular surgeon for additional patient care.At this time, it is unknown whether the patient was plavix resistant.The patient status is unknown.
 
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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
magaly boardman
1213 innsbruck drive
sunnyvale, CA 94089
4087309002
MDR Report Key11662636
MDR Text Key245368633
Report Number3014526664-2021-00043
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00811311020508
UDI-Public(01)00811311020508(17)210331(10)17858026
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 04/13/2021
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-0940-CS
Device Catalogue NumberSR-0940-CS
Device Lot Number17858026
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/17/2021
Initial Date FDA Received04/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2019
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) Disability;
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