MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; ENROUTE NPS, NEUROPROTECTION SYSTEM, NPS

Model Number SR-200-NPS

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/22/2019

Event Type  Injury  

Event Description

Patient was experiencing vertigo was brought in for an ultrasound which demonstrated limited flow in his carotid artery.The patient underwent corrective open surgery which confirmed a partial obstruction of the common carotid artery from a subintimal hematoma.The stent previously put in place was removed.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: ENROUTE NPS, NEUROPROTECTION SYSTEM, NPS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: sharon rideout ; 1213 innsbruck drive; sunnyvale, CA 94089
• MDR Report Key: 8661232
• MDR Text Key: 146791447
• Report Number: 3014526664-2019-00021
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)190917(10)300043
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2019

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: 09/27/2019
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 06/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR