MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; EMBOLIC PROTECTION FILTERING GUIDEWIRE

Model Number	FG12531
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)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was also not provided to bsc.We made a good-faith effort to obtain this information.Because the lot number is unknown at this time, we are unable to provide the complete unique device identifier (udi) and other specific product details.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient had an embolic stroke after the procedure.An enroute transcarotid neuroprotection system (nps) was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The procedure was completed with no notable issues.Post procedure, during recovery, the patient blood pressure dropped to 69mmhg and remained hypotensive for approximately seven to ten minutes.The next day, the patient experienced left side symptoms and had a stroke.Imaging revealed new white lesions (nwl) in the right hemisphere, in the internal watershed zones and between the right anterior cerebral artery (aca) and middle cerebral artery (mca) territories.No intervention was performed and the stroke symptoms were resolved within four days.
Additional Manufacturer Narrative
Investigation results: a ship history review for the reported upn was performed for the reporting customer.Batches (498905), (474255) and (474744) were most recently shipped to the reporting facility in the 3-year period preceding the procedure date.There were no manufacturing deviations for any of the three batch numbers that could have contributed to the reported event.Review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.A risk review performed for an enroute tc neuroprotection system plus device confirmed that the event of ischemia stroke and low blood pressure/ hypotension are known events defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "known inherent risk of device".The lot number was also not provided to bsc.We made a good-faith effort to obtain this information.Because the lot number is unknown at this time, we are unable to provide the complete unique device identifier (udi) and other specific product details.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient had an embolic stroke after the procedure.An enroute transcarotid neuroprotection system (nps) was selected for use in a right sided transcarotid artery revascularization (tcar) procedure.The procedure was completed with no notable issues.Post procedure, during recovery, the patient blood pressure dropped to 69mmhg and remained hypotensive for approximately seven to ten minutes.The next day, the patient experienced left side symptoms and had a stroke.Imaging revealed new white lesions (nwl) in the right hemisphere, in the internal watershed zones and between the right anterior cerebral artery (aca) and middle cerebral artery (mca) territories.No intervention was performed and the stroke symptoms were resolved within four days.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Common Device Name: EMBOLIC PROTECTION FILTERING GUIDEWIRE
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 27th ave north plymouth; minneapolis MN 55447
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24598195
• Report Number: 2124215-2026-14136
• Device Sequence Number: 9507485
• Product Code: NTE
• UDI-Device Identifier: 00811311021062
• UDI-Public: (01)00811311021062
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 04/21/2026

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 Model Number: FG12531
• Device Catalogue Number: FG12531
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Race: White