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 Infarction, Cerebral (1771); Dysphasia (2195); Patient Problem/Medical Problem (2688)

Event Date 07/25/2019

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.Please note that this event was evaluated and determined to be unrelated to a silk road medical product.Out of an abundance of caution, this report is being filed.

Event Description

It was reported that an asymptomatic (b)(6) year old male patient underwent a left transcarotid artery revascularization (tcar) procedure on (b)(6) 2019 at 10am.On (b)(6) 2019 at 6pm an srm principal therapy development specialist was notified by the physician that the patient suffered dysphasia at 4am on (b)(6) 2019 and right arm weakness between 8-9 am.Computerized axial tomography (ct) of head was performed and was negative for bleed.The cta showed patent stent and the dwmri showed 2 tiny punctuate infarcts in the left frontal lobe and a single punctuate infarct in the left parietal lobe.Patient was in atrial fibrillation which was bridged with heparin.Patient went into supraventricular tachycardia (svt) at the beginning of the case.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 drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck drive; sunnyvale 94089
• MDR Report Key: 8928018
• MDR Text Key: 159609909
• Report Number: 3014526664-2019-00062
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)210117(10)300377
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2021
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2019
• 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): Required Intervention
• Patient Age: 86 YR