MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC. ENROUTE TRANSCAROTID 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 Problem Patient Problem/Medical Problem (2688)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

This event is being reported out of an abundance of caution.On 17dec2019 silk road medical contacted osb to inform them of medical device reports that were not reported within the mandatory reporting timeframe.It is noted here, per fda's request, that this mdr was identified as part of a complaint handling remediation effort associated with capa-(b)(4).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 identified that could lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

Patient underwent right transcarotid artery revascularization on (b)(6) 2017.Patient complained of problems with his right eye in the rr post procedure.The post-procedure nihss was zero (0).On (b)(6) 2017 the patient woke up with left hand and great toe numbness and was instructed to go to the er by the vascular resident on call.No focal neurological deficit was observed and cn ii-xii were intact.Normal sensory, normal motor and normal speech were observed.Left arm and leg numbness/weakness was resolved.Patient was discharged home after mri and ct.Patient seen in vascular clinic on (b)(6) 2017 with no improvement in right eye vision.Nihss is zero (0).Carotid duplex shows rica <50%.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• 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 ; 4087209002
• MDR Report Key: 9640015
• MDR Text Key: 179311264
• Report Number: 3014526664-2020-00014
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)180728(10)200913
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 200913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• 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): Other; Disability