MAUDE Adverse Event Report: SILK ROAD MEDICAL 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 10/25/2022

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 after a right transcarotid artery re-vascularization (tcar) procedure, the patient had stroke-like symptoms.Computed tomography angiography (cta) showed an occluded stent (ischemic, no bleed).A thrombectomy was performed to open the stent.The patient's medication was switched to brilinta; however, there was no conclusive evidence provided that the patient was plavix resistant.P2y12 test was not performed on this patient.At this time, it is unknown if the reported failure is related to a enroute transcarotid stent system (tss) failure, procedural issues or patient resistance to medication, 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; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: shelrin devi ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 15817930
• MDR Text Key: 303901581
• Report Number: 3014526664-2022-00182
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)240831(10)18052536
• 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: 11/16/2022

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 Expiration Date: 08/31/2022
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 18052536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Male