MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85453

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/26/2015

Event Type  Injury  

Event Description

During aortic stent graft procedure the physician was deploying a stent in the left renal artery when the stent became loose on the balloon.The physician was able to "shimmy" the stent on the balloon and implanted it at the target renal artery.

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.Associated file: 1219977-2015-001756.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4814401
• MDR Text Key: 5892492
• Report Number: 1219977-2015-00161
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 218655
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Date Device Manufactured: 12/01/2014
• 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