MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM V12 COVERED STENT; PTFE COVERED STENT

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Stenosis (2263)

Event Type  Injury  

Event Description

Received an article titled "fenestrated endografting of juxtarenal aneurysms after open aortic surgery" that was published on the journal of vascular surgery in (b)(6) 2014.The study consisted of the experience with fenestrated endovascular aneurysm repair (f-evar) in the treatment of juxtarenal aneurysms after previous open surgery.The study involved 35 patients from 2003 through 2013.Per the study, seven patients with deployment difficulty related to severe stenosis and angulation.

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study, fenestrated endovascular aneurysm repair (f-evar) is a valid treatment method in cases of proximal para-anastomotic aneurysms (paa's) or progressive juxtarenal aneurysmal degeneration after open repair.Per the study, although additional technical difficulties in comparison to primary f-evar in the native aorta should be acknowledged, it clearly represents a less morbid alternative to open conversion, has a high technical success rate, and has durability in midterm follow-up.Associated files: 1219977-2015-00014,00028.

• Brand Name: ATRIUM V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645366
• MDR Report Key: 4459616
• MDR Text Key: 5318979
• Report Number: 1219977-2015-00027
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Date FDA Received: 01/27/2015
• 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
• Date Manufacturer Received: 01/05/2015
• 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