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

Model Number SR-0640-CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 07/17/2019

Event Type  Injury  

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 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
• Type of Device: ENROUTE SDS
• 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: 1213 innsbruck drive; sunnyvale, CA 94089
• MDR Report Key: 8903145
• MDR Text Key: 154758534
• Report Number: 3014526664-2019-00058
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020416
• UDI-Public: (01)00811311020416(17)200430(10)300439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR