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

Model Number SR-1040-CS

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

Patient Problems Stroke/CVA (1770); Hemorrhagic Stroke (4417)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint was not returned to the manufacturer for analysis.A review of manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.Although there is no indication that a malfunction of the srm device occurred, the cause of the post-operative complication is unknown.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.

Event Description

It was reported after the completion of a right transcarotid artery revascularization (tcar) procedure, the patient experienced left upper extremity and lower extremity weakness, bilateral arm contractions and difficulty speaking roughly 9 hours post procedure.Emergent computed tomography (cta) demonstrated stent compression at the bifurcation.The patient was brought into the operating room (or) for stent percutaneous transluminal angioplasty (pta) via tcar approach.Additional information indicated the patient's cta did not demonstrate a hemorrhagic stroke.The patient was reported as stable as neuro deficits have resolved.This report is being submitted out of an abundance of caution, as it is unclear if the adverse event was caused by the procedure, patient response or the manufacturer's device.

Manufacturer Narrative

This follow-up supplemental report #1 is being submitted to correct an inadvertent entry error in h6, adverse event problem (health effect-clinical code).

Event Description

It was reported after the completion of a right transcarotid artery revascularization (tcar) procedure, the patient experienced left upper extremity and lower extremity weakness, bilateral arm contractions and difficulty speaking roughly 9 hours post procedure.Emergent computed tomography (cta) demonstrated stent compression at the bifurcation.The patient was brought into the operating room (or) for stent percutaneous transluminal angioplasty (pta) via tcar approach.Additional information indicated the patient's cta did not demonstrate a hemorrhagic stroke.The patient was reported as stable as neuro deficits have resolved.This report is being submitted out of an abundance of caution, as it is unclear if the adverse event was caused by the procedure, patient response or the manufacturer's device.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC; 1213 innsbruck drive; sunnyvale CA 94089 1317
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: jasneet bedi ; 1213 innsbruck drive; sunnyvale, CA 94089-1317 ; 4087209002
• MDR Report Key: 13350013
• MDR Text Key: 284449098
• Report Number: 3014526664-2022-00013
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)240531(10)18030866
• 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: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 18030866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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: 73 YR
• Patient Sex: Male