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

Model Number 85445

Device Problems Premature Activation (1484); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2015

Event Type  Injury  

Event Description

Report received on an aneurysm repair case and the target vessel was the renal artery.The physician was attempting to advance the stent through the introducer sheath and he had to take the stent in and out of the sheath once.The stent came off the balloon during the delivery.No harm came to the pt.

Manufacturer Narrative

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

• Brand Name: ATRIUM ICAST COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4634830
• MDR Text Key: 22155369
• Report Number: 1219977-2015-00093
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 85445
• Device Catalogue Number: 85445
• Device Lot Number: 216777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2015
• Date Device Manufactured: 09/01/2014
• 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: 7FR X 55 CM ANSEL 1 INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 68