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

Model Number SR-0930-CS

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

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

Event Date 04/17/2022

Event Type  Death  

Event Description

It was reported that two days after completion of a left transcarotid artery revascularization (tcar) procedure, the patient's stent thrombosed.A stroke occurred, and the patient was paralyzed on the right leg and arm.The physician performed a thrombectomy and balloon angioplasty and placed the patient on ticagrelor/brilinta.Additional information received on (b)(6) 2022 indicated that patient was in the hospital for 30 days and then was discharged.The patient went to a rehabilitation facility and subsequently passed away.The cause and date of death are unknown.At this time, there is no indications as to what may have caused the thrombus, or if the reported failure is related to procedural issues, patient resistance to dual antiplatelet therapy (dapt) medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.

Manufacturer Narrative

A secondary mdr was reported under 3014526664-2022-00076 as there are two stents associated with the same event/patient.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.

• 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: 14593468
• MDR Text Key: 293273782
• Report Number: 3014526664-2022-00077
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)240331(10)18014011
• 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: 06/03/2022

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: 03/31/2024
• Device Model Number: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 18014011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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; Death; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male