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

Device Problems Kinked (1339); Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Received an article titled "comparison of fenestrated endografts and the snorkel/chimney technique" that was published on the journal of vascular surgery in october 2014.The study consisted of comparing the early learning curve at a single institution of fenestrated repair vs the snorkel technique in abdominal aortic aneurysm repair.The study involved 35 patients with snorkel endovascular aneurysm repair (sn-evar) and 15 patients with fenestrated endovascular aneurysm repair (f-evar) from 2009 through 2013.Per the study, one patient experienced an occluded left renal stent that was kinked on post-op day 2 and was restented.

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study, the early experiences of fenestrated endovascular aneurysm repair (f-evar) was similar to that of snorkel endovascular aneurysm repair (sn-evar) in terms of patient demographics, case selection, and procedural characteristics.Per the study, a significant portion of the learning curve for both procedures, particularly for f-evar, lies in the preoperative planning of fenestrations and the cannulation of branch vessels.Per the study, similar short-term postoperative outcomes between these two particular techniques indicate that both will have utility in the treatment of high-risk patients with complex anatomy.Associated files: 1219977-2015-00018,00019,00020,00021,00022.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDIBLE
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645366
• MDR Report Key: 4459628
• MDR Text Key: 16990501
• Report Number: 1219977-2015-00023
• 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

• 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