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

Catalog Number	SR-0840-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of consciousness (2418); Ischemia Stroke (4418)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day after a right transcarotid artery revascularization (tcar) procedure, the patient was found unresponsive at their home.Imaging revealed bilateral multifocal lesions and a patent stent.The patient has not made a complete recovery.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.
Additional Manufacturer Narrative
This follow-up mdr is being submitted to indicate that the initial mdr report is being retracted as there is no evidence that a silk road medical device caused or contributed to an adverse event.Additional information can be found in the following fields: b4: date of this report, b5: describe event or problem, g3: date recieved by manufacturer, g6: type of report, h2: if follow up, what type?, h11: additional manufacturer narrative.
Event or Problem Description
This supplemental mdr is being submitted for additional information received on december 18, 2024: the patient experienced right sided symptoms after the right transcarotid artery revascularization (tcar) procedure.The symptoms are not consistent with the relationship with right sided disease and treatment, as any emboli generated from the right treated side and going to the brain would result in symptoms on the contralateral side (left side) of the body.Given the patient passed the neurological check post procedure, the stent was patent, and the reported neurological stroke symptoms presented on the same side as the treated carotid, the evidence does not support the stroke is related to a silk road medical device.Although imaging revealed multifocal lesions on the right side, the source of the lesions and timing is unknown and as the patient did not experience any symptoms on the left side (contralateral to the right tcar) this event will be deemed as non-reportable.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer Contact: vincent lopez mireles ; 1213 innsbruck dr.; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 20919462
• Report Number: 3014526664-2024-00234
• Device Sequence Number: 5293967
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)260930(10)18250656
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K230402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/14/2025

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: 09/30/2026
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 18250656
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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: Disability
• Patient Age: 74 YR
• Patient Sex: Female