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

Model Number	SR-0740-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	08/16/2023
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.At this time, it is unknown if the reported failure is related to procedural issues, non-compliance to medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends and a supplemental mdr will be submitted if additional information is received.B3 field: the exact date of the event is unknown and has been capatured based on the decription provided in b5.
Event or Problem Description
It was reported that three weeks after a transcarotid artery revascularization (tcar) procedure, the patient had a stroke.Imaging revealed thrombus within the stent.The physician performed thrombectomy to address the issue.At this time, it is unknown if the reported failure is related to procedural issues, non-compliance to medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
Event or Problem Description
On 20th may 2024, a literature reference was received by the manufacturer, which indicated that three weeks after a left transcarotid artery revascularization (tcar) procedure, the patient experienced aphasia, right arm weakness, and altered mental status.The patient was discharged on 81mg aspirin and clopidogrel but, aspirin was later discontinued due to reflux.Imaging revealed distal left m1 occlusion, thrombus within the stent and pseudoaneurysm in the common carotid artery at the access site.Further, imaging findings also indicated intramural hematoma at the access site with underfilling of the distal left internal carotid artery (ica).The physician performed thrombectomy to treat the thrombus and placed a carotid stent to treat pseudoaneurysm.The reported events of pseudoaneurysm and hematoma are a procedural complication and were not related to a silk road medical device.
Additional Manufacturer Narrative
Title: thrombectomy and stenting of pseudoaneurysm from transcarotid artery revascularization.Author: jason h boulter, michael f.Stiefel, eyal ben-aire , albert j.Schuette doi: 10.25259/ sni_71_2024.Additional/updated information can be found in the following fields: b3: date of event.B4: date of this report.B5: describe event or problem.B7: other relevant history, including preexisting medical conditions.G2: report source.G6: type of report.H2: if follow up, what type?.H11: additional manufacturer narrative.

• 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: 17759865
• Report Number: 3014526664-2023-00150
• Device Sequence Number: 12416768
• Product Code: NIM
• UDI-Device Identifier: 00811311020447
• UDI-Public: (01)00811311020447(17)250630(10)18126706
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 06/30/2025
• Device Model Number: SR-0740-CS
• Device Catalogue Number: SR-0740-CS
• Device Lot Number: 18126706
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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: 64 YR
• Patient Sex: Male