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

Model Number 85417

Device Problems Deflation Problem (1149); Material Separation (1562)

Patient Problems Stenosis (2263); Vascular Dissection (3160)

Event Date 05/22/2014

Event Type  Injury  

Event Description

Patient had an abdominal aortic aneurysms (aaa) procedure with an aorta-uni stent graft and double chimney stent.At the target location, the physician re-inflated the stent.During this inflation, the stent would not attain nominal pressure.During removal, the balloon did not deflate and could not be removed and the hub separated from the shaft.As it was removed it was discovered that the lunderquist wire also traveled into the arm with the stent delivery system.Once the lunderquist wire was retracted into the aorta, the stent delivery system was finally removed.Upon inspection it was discovered that the balloon was bunched to one end of the catheter.A balloon was then inflated in the vessel to ensure that the stent was fully inflated.The patient's left arm developed a stenosis and dissection (tear) which required a brachial cut down and bare metal stent placement to handle the dissection.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

• Brand Name: ICAST COVERED STENT
• Type of Device: COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr. specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3929728
• MDR Text Key: 4535479
• Report Number: 1219977-2014-00187
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 85417
• Device Catalogue Number: 85417
• Device Lot Number: 206489
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• Date Device Manufactured: 04/01/2014
• 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