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

Model Number 85453

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 02/04/2015

Event Type  Injury  

Event Description

During a procedure on an occluded superior mesenteric artery, the stent was introduced into the sheath.The clinician accidentally pulled the wire backward.The stent was pulled back through the sheath and was noted to be off the catheter.

Manufacturer Narrative

On 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 CORP.; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4543886
• MDR Text Key: 18894496
• Report Number: 1219977-2015-00044
• 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: Other
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2015
• Date Device Manufactured: 10/01/2014
• 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