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

Model Number SR-0740-CS

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

Patient Problem Ischemia Stroke (4418)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint was not returned to the manufacturer for analysis.A review of the 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, therefore, the complaint will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.A supplemental mdr will be submitted if additional information is received.

Event Description

It was reported that 7-8 days after the completion of a transcarotid artery revascularization (tcar) procedure performed on (b)(6) 2022, the patient exhibited limb shaking transient ischemic attacks (tia).Magnetic resonance imaging (mri) showed infarcts on the left side, and computed tomography (ct) showed the enroute stent was open but had narrowed by 80-90%.The physician elected to repeat tcar to dilate the narrowing with a 6mm balloon.The patient became hypotensive after receiving protamine, and the following day, the patient experienced right hand shaking, headaches, and nausea.The physician stated the patient had a major stroke.Ct showed the stent was open, but the physician elected to explant the stent via carotid endarterectomy (cea).Mri performed on (b)(6) 2022 showed two white spots on the left front parietal lobes.The patient was noted to be recovering in the intensive care unit (icu) and was not able to use her right arm and was not able to swallow.At this time, it is unknown if the reported event of new white lesions is related to procedural interventions (tcar or cea), or a silk road medical device failure, hence, the event will be reported out of abundance of caution.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE TSS
• 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: magaly boardman ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 15215064
• MDR Text Key: 297761236
• Report Number: 3014526664-2022-00120
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020447
• UDI-Public: (01)00811311020447(17)240831(10)18054175
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SR-0740-CS
• Device Catalogue Number: SR-0740-CS
• Device Lot Number: 18054175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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): Disability; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female