MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE NEUROPROTECTION SYSTEM; MPS

Model Number SR-200-NPS

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

Patient Problems Death (1802); Brain Injury (2219)

Event Date 03/21/2020

Event Type  Death  

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 lead to the adverse event reported.Complaints will continue to be reviewed and monitored for trends.

Event Description

Patient underwent transcarotid artery revascularization procedure on the right carotid artery.The procedure was executed without issue.The following day, the patient suffered from an embolic stroke, and subsequently passed away.

• Brand Name: ENROUTE NEUROPROTECTION SYSTEM
• Type of Device: MPS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer Contact: sharon rideout ; 1213 innsbruck drive; sunnyvale, ca ; 7209002
• MDR Report Key: 9998561
• MDR Text Key: 188963586
• Report Number: 3014526664-2020-00053
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220708(10)300867
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153485
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300867
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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): Death
• Patient Age: 78 YR