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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Event Description

Received an article titled "outcomes of covered versus bare-metal balloon-expandable stents for aortoiliac occlusive disease that was published on the journal of vascular surgery in august 2014.The study evaluated midterm outcomes of bare metal stents and covered balloon expandible stents placed in the common iliac artery (cia) for aortoiliac occlusive disease at a single institution from 2006 to 2012 involving 254 procedures performed on 162 patients.Per the study, 5 patients experienced arterial thrombosis requiring intervention.

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study, gender, continued use of statins medications, smoking status, bilateral common iliac artery (cia) treatment, lesion length and transatlantic inter-society consensus (tasc) classification were not predictive of primary patency.Multivariate analysis revealed dual antiplatelet therapy to be a factor to affect patency during long-term follow-up.

• 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: 4448189
• MDR Text Key: 5428508
• Report Number: 1219977-2015-00005
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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