MAUDE Adverse Event Report: SILK ROAD MEDICAL INC ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS

Model Number SR-0940-CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 10/19/2022

Event Type  Injury  

Event Description

It was reported that 7 hours after a right transcarotid artery revascularization (tcar) procedure, the patient had a thrombotic stroke and left arm and leg weakness with slight facial droop.Thrombus was found distal to the stent, which was treated with thrombectomy, but the patient still had left arm and leg weakness and slight facial droop.The physician also switched the patient's medication to brilinta at the onset of stroke symptoms; however there was no conclusive evidence provided that the patient was plavix resistant.At this time, there is no conclusive evidence if the patient was plavix resistant.As this event could be associated with the enroute transcarotid stent system (tss), it will be reported out of abundance of caution.

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.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.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC; 1213 innsbruck drive; sunnyvale CA 94089 1317
• Manufacturer (Section G): SILK ROAD MEDICAL INC; 1213 innsbruck drive; sunnyvale CA 94089 1317
• Manufacturer Contact: jasneet bedi ; 1213 innsbruck drive; sunnyvale, CA 94089-1317 ; 4087209002
• MDR Report Key: 15785269
• MDR Text Key: 303552729
• Report Number: 3014526664-2022-00172
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)250331(10)18104104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140026
• 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: 11/11/2022

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 Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 18104104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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: Female