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 Infarction, Cerebral (1771); Patient Problem/Medical Problem (2688)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for evaluation for analysis.Therefore, the root cause of this adverse event cannot be identified at this time.A review of the 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 monitored for any trends.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).

Event Description

It was reported that a stroke may have occurred on (b)(6) 2018 after the transcarotid artery revascularization (tcar) procedure.An mri revealed multiple infarcts in the left major carotid artery and the patient had developed right-sided weakness and aphasia in recovery.Patient was slow to wake.The intracranial angiogram was unremarkable.The patient was on dapt and statin.

• Brand Name: ENROUTE NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck dr.; sunnyvale, CA 94089
• MDR Report Key: 9645257
• MDR Text Key: 179311713
• Report Number: 3014526664-2020-00019
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)190512(10)201262
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2019
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 201262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability