MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM BALLOON EXPANDABLE PTFE COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85418

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

Patient was having surgery for endovascular thoracoabdominal aortic aneurysm repair when the stent prematurely separated from the delivery system.Surgeon able to retrieve undeployed stent completely.Fda safety report id# (b)(4).

• Brand Name: ATRIUM BALLOON EXPANDABLE PTFE COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION
• MDR Report Key: 12506842
• MDR Text Key: 272867220
• Report Number: MW5104099
• Device Sequence Number: 1
• Product Code: JCT
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 85418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2021
• 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 Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 71