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 Problems Weakness (2145); Cognitive Changes (2551); Patient Problem/Medical Problem (2688)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for evaluation.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.

Event Description

It was reported that a left transcarotid artery revascularization (tcar) was performed on a (b)(6) year old symptomatic male, under regional block and light conscious sedation.The patient was fully respondent post clamping until pre dilation.Just after stent deployment, the patient was very slow to respond to voice commands.A discussion of sedation vs intolerance occurred.After a two minute wait period, an angiogram was performed showing successful stent deployment with full patency.The physician pulled the guidewire and unclamped.The patient slowly become more arousable but still showed cognition impairment.Upon completion of closure, the patient continued to improve and was responding to commands, but unable to make first contralaterally.A decision to notify neuro was made to evaluate for potential stroke.Neuro exam showed mild aphasia with extremity weakness and cognition impairment.A computed tomography (ct scan) showed no evidence of embolic obstruction or hemorrhagic event.The patient was still improving 6 hours post procedure.Magnetic resonance angiography (mra) showed multiple acute amboli.No additional details were provided.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck road; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck drive; sunnyvale, CA 94089
• MDR Report Key: 8985878
• MDR Text Key: 161218850
• Report Number: 3014526664-2019-00064
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220122(10)300395
• 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: 09/10/2019

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: 01/22/2022
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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): Required Intervention
• Patient Age: 77 YR