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

Model Number	SR-0830-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Brain Injury (2219)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ct imaging six days after procedure suggested either plaque prolapse or platelet aggregation on the stent.P2y12 inhibitor testing was conducted but immediately after brillinta was initiated.The testing results indicated therapeutic levels; therefore, it is unknown whether the patient was plavix resistant.Although there is no indication that a malfunction of the srm device occurred, the cause of the post-operative complication is unknown.This is being reported out of an abundance of caution.A follow-up mdr will be submitted if additional information is obtained.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.A secondary mdr is submitted under 3500a form # 3014526664-2020-00098 since at this time it is unknown which device may have caused or contributed to the reported event.Silk road medical will continue to monitor for occurrences of similar events.
Event or Problem Description
It was reported that six days after the completion of a transcarotid artery revascularization (tcar) procedure, the patient experienced a stroke.The patient has since recovered and is neuro intact.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 10730740
• Report Number: 3014526664-2020-00101
• Device Sequence Number: 11625849
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)211231(10)17920433
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/23/2020

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: 12/31/2021
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 17920433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: Disability
• Patient Age: 69 YR