MAUDE Adverse Event Report: SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS

Model Number	SR-0830-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional 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.Complaints will continue to be reviewed and monitored for trends and a supplemental mdr will be submitted if additional information is received.At this time, it is unknown if the reported failure is related to a enroute transcarotid stent system (tss) failure or patient resistance to medication, or a procedural complication, hence, the event will be reported out of abundance of caution.
Event or Problem Description
It was reported that shortly after the completion of a transcarotid artery revascularization (tcar) procedure, the patient experienced a thrombosed stent and neurological symptoms which led the physician to explant the enroute stent.At this time, it is unknown if the reported failure is related to a enroute transcarotid stent system (tss) failure or patient resistance to medication, or a procedural complication, hence, the event will be reported out of abundance of caution.
Additional Manufacturer Narrative
On 05/09/2023, silk road medical received additional information regarding the patient's case.The thromboelastography (teg) test results indicate that the patient was likely resistant to clopidogrel.The multiplate adenine di-phosphate testing (ma-adp) showed a value of 49mm.It is important to note that if ticagrelor had not been administered prior to the test, the ma-adp value would likely have been much higher, indicating no platelet inhibition by clopidogrel.Based on the new information received, the patient experienced a thrombosed stent and neurological symptoms, which prompted the physician to remove the enroute stent.The test results provided to silk road medical indicated that the patient exhibited resistance to clopidogrel.It is determined that this event is associated with the medication/patient response, specifically clopidogrel resistance.There is no evidence to suggest that a silk road medical device caused or contributed to the adverse event, nor is there any indication of a device malfunction.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: 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: magaly boardman ; 1213 innsbruck drive; sunnyvale, CA 94089-1317 ; 4087209002
• MDR Report Key: 16499723
• Report Number: 3014526664-2023-00034
• Device Sequence Number: 6611108
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)250430(10)18110093
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 18110093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female