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

Catalog Number SR-0830-CS

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

Event Description

A (b)(6) year old female was present for a left transcarotid artery stent placement due to severe asymptomatic bilateral (left more irregular than right) carotid artery stenosis.During the procedure, angiogram showed a very long lesion with mid and distal cca disease that the surgeon planned to cover.Pre-dilation was performed with a 5 x 20 mm bsc balloon.An 8 x 30 mm enroute stent was then placed from the mid ica through the distal cca.A second 8 x 30 mm enroute stent was then placed just outside the sheath into the proximal ica with standard overlap.This was deployed in typical fashion, however the stent did not unsheath.Despite this, the surgeon was able to remove it off the wire.An 8 x 40 mm enroute stent was then placed and deployed from the proximal ica through the mid cca, just outside of the sheath tip.The remainder of the procedure was performed without further incident and the patient went to the recovery room in stable condition without complications.Fda safety report id # (b)(4).

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.
• MDR Report Key: 10118578
• MDR Text Key: 194178349
• Report Number: MW5094829
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 17918071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 88