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

Model Number SR-1030-CS

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

Patient Problem Vascular Dissection (3160)

Event Date 09/21/2021

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 identified on the left internal carotid artery during stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.Per silk road medical's field representative, it was noted that the physician wasn't sure if the dissection was caused by the balloon or stent, and it is believed that the physician leaned toward the stent.However, he did not perform imaging after the balloon angioplasty so there is no way to be certain.The procedure was completed successfully and the patient's clinical condition after the procedure completion remained neurologically intact.

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection was identified on the left internal carotid artery during stent placement angiogram which led the physician to intervene by covering the dissection with a secondary stent to resolve.Per silk road medical's field representative, it was noted that the physician wasn't sure if the dissection was caused by the balloon or stent, and it is believed that the physician leaned toward the stent.However, he did not perform imaging after the balloon angioplasty so there is no way to be certain.The procedure was completed successfully and the patient's clinical condition after the procedure completion remained neurologically intact.

Manufacturer Narrative

A follow-up mdr is being submitted to reflect the correct model number and catalog number under section d4: additional device information.

• 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: 12551133
• MDR Text Key: 274054877
• Report Number: 3014526664-2021-00149
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020522
• UDI-Public: (01)00811311020522(17)240229(10)18011799
• 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: 11/05/2021

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: 02/29/2024
• Device Model Number: SR-1030-CS
• Device Catalogue Number: SR-1030-CS
• Device Lot Number: 18011799
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2021
• 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: 87 YR
• Patient Sex: Female