MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDIBLE

Model Number 85453

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 12/22/2014

Event Type  Injury  

Event Description

The stent was noticed to have slipped off the balloon while attempting to pass it through the hemostatic valve of the introducer sheath.

Manufacturer Narrative

Our completion of the investigation, a follow up report will be submitted.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDIBLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth drive; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4493697
• MDR Text Key: 5327590
• Report Number: 1219977-2015-00031
• 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: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 218624
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK ANSEL 6 FR SHEATH
• Patient Outcome(s): Required Intervention