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 Vascular Dissection (3160); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint was not returned to the manufacturer for analysis.A review of manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.Although there is no indication that a malfunction of the srm device occurred, the cause of the post-operative complication is unknown.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.

Event Description

It was reported that 6 days after the completion of a transcarotid artery revascularization (tcar) procedure, the patient returned to the hospital experiencing a fall and stroke.A dissection was identified on the common carotid artery (cca), and the stent was noted to be compressed.The patient underwent an open exploration procedure to repair the cca and explant the stent, and a carotid endarterectomy (cea) was performed.The patient was reported to be okay post-procedure.Per the physician, the cause of the dissection was due to clamping for access of the enroute arterial sheath, and the cause of the thrombus was due to intimal disruption from the dissection.The thrombus was located on the cca at the stitch and site of cannulation of the dissection.Magnetic resonance imaging (mri) revealed acute or early subacute infarcts at the right basal ganglia to the corona radiata and centrum semiovale ovale, and several scattered tiny embolic cortical infarcts in the right frontal, parietal and occipital lobes.No further patient complications were reported.

• 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 94089
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: yvonne nguyen ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 14322182
• MDR Text Key: 291216100
• Report Number: 3014526664-2022-00063
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)241020(10)302234
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 302234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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; Disability
• Patient Age: 79 YR
• Patient Sex: Male