MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Catalog Number	SR-200-NPS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Muscle Weakness/Atrophy (1967); Ischemia Stroke (4418)
Date of Event	02/14/2025
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.The reported event is a mixed pattern event, and since the patient experienced symptoms during the post procedure neurological check, this will be reported for the enroute transcarotid neuroprotection system (nps) out of an 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.
Event or Problem Description
It was reported that after a left transcarotid artery revascularization (tcar) procedure, the patient failed the post procedure neurological check and was unable to move their right hand.The patient was on plavix and aspirin but not on statins due to statin allergies.Additional information stated that emboli was noted in the right middle cerebral artery (mca), contralateral to the treatment side.The physician elected to perform a thrombectomy and the patient has not returned to baseline.It was determined by the physician that the event was due to the patient's underlying condition of atrial fibrillation.However, the silk road medical executive medical director reviewed the magnetic resonance imaging (mri) on (b)(6) 2025 and noted that new white lesions were present in the cerebellum, in watershed zones, and the left motor strip.The cerebellum is supplied by the vertebrobasilar arteries which are not interacted with during the tcar procedure, hence the emboli in the cerebellum are unrelated to the procedure.The motor strip is supplied by the carotid arteries, and the approximate age of the lesions in the motor strip indicated that they may be related to the timing of the tcar procedure.The reported event is a mixed pattern event, and since the patient experienced symptoms during the post procedure neurological check, this will be reported for the enroute transcarotid neuroprotection system (nps) out of an abundance of caution.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Common Device Name: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• 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: 21756795
• Report Number: 3014526664-2025-00057
• Device Sequence Number: 15865070
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)261206(10)305573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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 Catalogue Number: SR-200-NPS
• Device Lot Number: 305573
• 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: 02/14/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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: Required Intervention; Disability
• Patient Age: 81 YR
• Patient Sex: Male