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

Model Number	SR-200-NPS
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Insufficient Flow or Under Infusion (2182); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Dysphasia (2195)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was inadequate flow within in the device.The patient presented as symptomatic for a right transcarotid revascularization (tcar) procedure.An enroute transcarotid neuroprotection system (nps) was selected for use.During the procedure, a flush bolus was administered to confirm reverse flow; however, only minimal flow was observed.The stopcocks, tubing, and arterial sheath position were verified, and blood pressure was maintained between 140 to 160 mmhg.Challenges in achieving adequate flow reversal were suspected to be related to femoral sheath placement in the femoral artery rather than the femoral vein, resulting in an inadequate pressure gradient.Venous sheath access was performed by a resident at the direction of the physician; however, it is unknown whether the access was arterial or venous.The physician elected to continue the procedure without exchanging the system.Final angiography suggested the presence of a small air bubble and a possible thrombus at the distal edge of the stent.Imaging angles were adjusted to assess for dissection; however, none was identified.During this time, air was noted within the nps tubing and arterial sheath.Reportedly, no dissection was identified in the left femoral artery.Cerebral angiography demonstrated no filling defects, and the previously suspected air bubble and thrombus were no longer visualized.The procedure was completed, and the patient was instructed to receive 100% oxygen for management of the suspected air embolism.The patient was transferred to the post-anesthesia care unit (pacu) for neurological monitoring.Initial left-sided immobility was reported; however, improvement was observed within approximately 30 minutes.The patient remained aphasic.Magnetic resonance imaging (mri) findings showed no evidence of acute infarct.The patient's left-sided movement fully recovered within approximately 45 minutes post-procedure.A delay in recovery was reportedly attributed to the patient's advanced age, prior history of stroke, and mild dementia.Upon review of the imaging by boston scientific medical director, no loss of intracranial branches was observed.The external carotid artery (eca) was occluded.There was no evidence of air embolism.

• 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: 25356200
• Report Number: 2124215-2026-29264
• Device Sequence Number: 9966785
• Product Code: NTE
• UDI-Device Identifier: 00811311020744
• UDI-Public: (01)00811311020744
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 0000305987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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
• Patient Age: 85 YR
• Patient Sex: Female