MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC ENROUTE NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

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 01/29/2020

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were "identifed" that could have lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

It was reported that a (b)(6) year old female underwent a right transcarotid revascularization procedure on (b)(6) 2020.On (b)(6) 2020, the patient presented to the er with stroke like symptoms.An mri was subsequently performed which showed the presence of frontal/parietal lobe infarction on the same side that the tcar procedure was performed.A ct scan was also performed which showed patent stent and vessels.It is unknown if the infarction was embolic or watershed.No additional details have been provided.

• Brand Name: ENROUTE NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL, INC; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer (Section G): SILK ROAD MEDICAL, INC; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer Contact: 1213 innsbruck drive; sunnyvale, ca
• MDR Report Key: 9746699
• MDR Text Key: 189081389
• Report Number: 3014526664-2020-00039
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)210206(10)300430
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• 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): Disability
• Patient Age: 75 YR