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

Model Number	SR-1030-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/21/2021
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 the manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.Complaints will continue to be reviewed and monitored for trends.
Event or Problem Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was identified on the left internal carotid artery during stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.Per silk road medical's field representative, it was noted that the physician wasn't sure if the dissection was caused by the balloon or stent, and it is believed that the physician leaned toward the stent.However, he did not perform imaging after the balloon angioplasty so there is no way to be certain.The procedure was completed successfully and the patient's clinical condition after the procedure completion remained neurologically intact.
Event or Problem Description
It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was identified on the left internal carotid artery during stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.Per silk road medical's field representative, it was noted that the physician wasn't sure if the dissection was caused by the balloon or stent, and it is believed that the physician leaned toward the stent.However, he did not perform imaging after the balloon angioplasty so there is no way to be certain.The procedure was completed successfully and the patient's clinical condition after the procedure completion remained neurologically intact.
Additional Manufacturer Narrative
A follow-up mdr is being submitted to reflect the correct model number and catalog number under section d4: additional device information.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: magaly boardman ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 12551133
• Report Number: 3014526664-2021-00149
• Device Sequence Number: 3990524
• Product Code: NIM
• UDI-Device Identifier: 00811311020522
• UDI-Public: (01)00811311020522(17)240229(10)18011799
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: 02/29/2024
• Device Model Number: SR-1030-CS
• Device Catalogue Number: SR-1030-CS
• Device Lot Number: 18011799
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2021
• 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
• Patient Age: 87 YR
• Patient Sex: Female