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 Problem Vascular Dissection (3160)

Event Date 09/29/2021

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.Complaints will continue to be reviewed and monitored for trends.

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was noticed on the right internal carotid artery after stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.The procedure was completed successfully, and the clinical condition of the patient is noted to be stable.It was noted that the patient's anatomy may have been a contributing factor to the dissection.The physician used multiple wires and catheters to try to cross, however it was not confirmed exactly at which point and what caused the dissection.There were many steps before the physician was even able to take a picture to see what was going on to see that a dissection occurred.Although it is noted that the dissection was caused by the patients difficult anatomy, at this time it is unknown if the stent may have caused or contributed to the dissection event, therefore, this case will be reported out of abundance of caution.

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was noticed on the right internal carotid artery after stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.The procedure was completed successfully, and the clinical condition of the patient is noted to be stable.It was noted that the patient's anatomy may have been a contributing factor to the dissection.The physician used multiple wires and catheters to try to cross, however it was not confirmed exactly at which point and what caused the dissection.There were many steps before the physician was even able to take a picture to see what was going on to see that a dissection occurred.Although it is noted that the dissection was caused by the patients difficult anatomy, at this time it is unknown if the stent may have caused or contributed to the dissection event, therefore, this case will be reported out of abundance of caution.

Manufacturer Narrative

Additional/updated information can be found in the following fields: b4: date of this report.G6: date received by manufacturer.G6: type of report.H2: if follow up, what type? a follow-up mdr is being submitted to reflect the correct date the information was provided to silk road medical in section g3.

• 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: 12609313
• MDR Text Key: 278190419
• Report Number: 3014526664-2021-00154
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)240430(10)18023943
• 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,Followup
• Report Date: 11/09/2021

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: 04/30/2024
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 18023943
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Female