MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS,

Model Number	SR-0930-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	03/16/2023
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.There is no indication that a malfunction of the srm device occurred; the cause of the post-operative complication is unknown, therefore, this report is being submitted out of an abundance of caution.Complaints will continue to be reviewed and monitored for trends.A supplemental mdr will be submitted if additional information is received.
Event or Problem Description
It was reported that post left transcarotid artery revascularization (tcar) procedure, the patient had some hypotension and became aphasic.The blood pressure was increased, and the aphasia resolved.However, the following morning, the patient again displayed aphasia and computed tomography angiography (cta) indicated compression of the carotid stent.Magnetic resonance imaging (mri) revealed bilateral new white lesions.The physician performed another transcarotid artery revascularization (tcar) procedure to balloon the prior placed stent.As the magnetic resonance imaging (mri) results are not consistent with left carotid treatment (new lesions on both hemispheres vs.New lesions on the left hemisphere) it is unknown if the reported failure is related to a patient medical condition, or a silk road medical device failure silk road medical will report the event out of an abundance of caution.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS,
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: shelrin devi ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 16708017
• Report Number: 3014526664-2023-00049
• Device Sequence Number: 14395610
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)250630(10)18125522
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/10/2023

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 Expiration Date: 06/30/2025
• Device Model Number: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 18125522
• 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: 03/16/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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: 75 YR
• Patient Sex: Female