MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENTS

Model Number 85454

Device Problem Activation Failure (3270)

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

Event Date 07/10/2014

Event Type  Injury  

Event Description

A stent was placed in left lower lobe through a bronchoscopy tube.The proximal aspect of the stent did not expand with pressure of 12 atmospheres obtained.The stent was removed with the bronchoscopy tube, then reinserted with a new stent with successful deployment.

Manufacturer Narrative

Upon completion of investigation a follow up report will be submitted.

• Brand Name: ATRIUM ICAST COVERED STENTS
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4028178
• MDR Text Key: 4800762
• Report Number: 1219977-2014-00229
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 85454
• Device Catalogue Number: 85454
• Device Lot Number: 201546
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 08/05/2014
• Date Device Manufactured: 01/01/2014
• 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
• Treatment: OLYMPUS BRONCHOSCOPE 2.8MM
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 79