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

Model Number SR-200-NPS

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

Patient Problems Brain Injury (2219); Patient Problem/Medical Problem (2688)

Event Date 02/07/2019

Event Type  Death  

Event Description

On (b)(6) 2019 dr (b)(6) called to inform me his left side tcar done on (b)(6) 2019 suffered a contra-lateral right occipital stroke with vision loss on post op day 4.Dr.(b)(6) scanned the implanted srm enroute stents and found them to be patent.There was no incident with any srm product used during this procedure.Addendum: on (b)(6) 2019 while in conversation, the physician informed the srm company representatives that the patient passed away while in the hospital.Physician said he was unsure if the death was related to tcar or from the stroke.He also stated the patient had developed a pneumonia and the patient's condition deteriorated over time and subsequently passed away.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: ENROUTE 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: branka spremo ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 8406440
• MDR Text Key: 138343073
• Report Number: 3014526664-2019-00002
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)191007(10)300099
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2019
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2018
• 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: 83 YR