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

Model Number	SR-0740-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	05/29/2021
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 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.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
Event or Problem Description
It was reported after the completion of a left transcarotid artery revascularization (tcar) procedure, the patient experienced an ischemic stroke.A computed tomography angiography (cta) showed severe stent compression.The physician elected to remove the stent to resolve the reported issue.The lesion was calcified and no p2y12 inhibitor test was performed on this patient.The patient was neurologically intact after the procedure.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC; 1213 innsbruck drive; sunnyvale CA 94089 1317
• MDR Report Key: 12046236
• Report Number: 3014526664-2021-00090
• Device Sequence Number: 4169336
• Product Code: NIM
• UDI-Device Identifier: 00811311020447
• UDI-Public: (01)00811311020447(17)231130(10)17991342
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: 11/30/2023
• Device Model Number: SR-0740-CS
• Device Catalogue Number: SR-0740-CS
• Device Lot Number: 17991342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 86 YR