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

Model Number	SR-200-NPS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred resulting in additional surgical intervention.An enroute transcarotid neuroprotection system was selected for use in the left transcarotid artery revascularization (tcar) procedure.During insertion of the arterial sheath, the j-wire came back, and imaging revealed a dissection from insertion area to bifurcation.Attempts were made to advance the 0.014 guidewire past the bifurcation but was unsuccessful.The wire and balloon were removed, and the arterial sheath was slightly pulled and adjusted but was unable to advance the guidewire.The procedure was converted to a carotid endarterectomy (cea) and the patient woke up neurologically intact.
Additional Manufacturer Narrative
We are unable to provide the complete unique identifier (udi) # at this time.Further investigation is in progress to obtain the complete unique identifier (udi) #.If additional details become available, a supplemental report will be submitted.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22183626
• Report Number: 2124215-2025-37651
• Device Sequence Number: 12904327
• Product Code: NTE
• UDI-Device Identifier: 00811311020744
• UDI-Public: (01)00811311020744
• 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
• Report Date (Section B): 06/11/2025

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 Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 0000306009
• 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: 05/16/2025
• Initial Report FDA Received Date: 06/11/2025
• Date Device Manufactured: 04/26/2024
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White