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	Muscle Weakness/Atrophy (1967); Ischemia Stroke (4418)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was also reported that a dissection occurred with an original equipment manufacture (oem) device that was addressed with a stent during the procedure.This information has been shared with the manufacturer.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 due to off label usage, patient resistance/ non-compliance to medication or a silk road medical device, hence will be reported 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 neurological check and was unable to squeeze their right hand.Imaging revealed multiple new white lesions in the left hemisphere.The patient's symptoms have not been resolved.The enroute neuroprotection system (nps) instructions for use (ifu) states that the nps is contraindicated in patients with severe disease of the ipsilateral common carotid artery as potential emboli could be dislodged during initial access and positioning of a guidewire.At this time, it is unknown if the reported event is due to off label usage, patient resistance/ non-compliance to medication or a silk road medical device, hence will be reported 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: 20872064
• Report Number: 3014526664-2024-00230
• Device Sequence Number: 18352419
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)270426(10)306009
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/06/2024

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: 306009
• 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: 11/12/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Disability
• Patient Age: 71 YR
• Patient Sex: Male