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

Model Number	SR-0640-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product in complaint was not returned to the manufacturer for analysis.Therefore, the root cause of this adverse event cannot be identified at this time.If the device should become available or additional information is obtained a supplemental report will be provided.Additionally, this was the first reported adverse event of this nature associated with this lot.Please see related mfr report 3014526664-2019-00059.
Event or Problem Description
It was reported that the patient baselined at the end of the procedure on (b)(6) 2019.The physician informed a silk road medical principal therapy development specialist, that the patient suffered a stroke overnight.The patient was sent to (b)(6) general health for neuro rescue, as both stents had thrombosed.It was also observed that there was a small dissection at the sheath tip during the procedure.However, the physician indicated that it did not need to be treated.No additional details were provided.

• 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: 8903145
• Report Number: 3014526664-2019-00058
• Device Sequence Number: 14065400
• Product Code: NIM
• UDI-Device Identifier: 00811311020416
• UDI-Public: (01)00811311020416(17)200430(10)300439
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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: 04/30/2020
• Device Model Number: SR-0640-CS
• Device Catalogue Number: SR-0640-CS
• Device Lot Number: 300439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/16/2019
• 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
• Patient Age: 75 YR