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

Model Number	SR-0940-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional/updated information can be found in the following fields: b2: outcomes attributed to adverse event.B4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: if follow up, what type?.H11: additional manufacturer narrative.
Event or Problem Description
This supplemental report is being submitted as additional information was received on 06/11/2024: it was reported that the patient had st-segment elevation myocardial infarction (stemi) post operatively on day 1 and the stent had thrombosed.The patient's family elected not to intervene and took the patient home on palliative care, where the patient passed away eight days post transcarotid artery revascularization (tcar) procedure.The physician indicated that this patient was in poor health due to comorbidities and was at high risk.Additionally, it was noted that the patient had stopped taking brilinta two days prior to tcar procedure and a loading dose of brilinta was administered to address the lack of adherence to dual antiplatelet therapy (dapt) protocol.The cause of death is unknown and occurred on palliative care subsequent to the patient's family's choice to not intervene for the event of thrombus.
Event or Problem Description
It was reported that the patient had a stroke within 48 hours after a left transcarotid artery revascularization (tcar) procedure.Imaging revealed stent was thrombosed.The patient was placed on heparin drip and no additional intervention was performed.Further, additional information indicated that eight days post-tcar procedure, the patient expired on palliative care.The physician stated that the primary cause of death was stroke.At this time, it is unknown if the reported event is related to procedural issues, patient resistance or non-compliance to medication, or a silk road medical device, hence, the event will be reported out of abundance of caution.
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.At this time, it is unknown if the reported event is related to procedural issues, patient resistance or non-compliance to medication, or a silk road medical device, hence, the event will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: shelrin devi ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 19272044
• Report Number: 3014526664-2024-00093
• Device Sequence Number: 12511745
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)260731(10)18230605
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/28/2024

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: 07/31/2026
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 18230605
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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: Death; Disability
• Patient Age: 75 YR
• Patient Sex: Male