MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC

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

Patient Problems Occlusion (1984); Blood Loss (2597)

Event Type  Injury  

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 results of the present study show that ch-endovascular aortic repair is a safe technique for patients who suffered from proximal para-anastomotic aneurysms and having short neck unsuitable for standard endovascular repair.

Event Description

Article received: karaolanis, g.E.(2019).Endovascular treatment of proximal para-anastomotic aneurysms after previous surgical repair of infrarenal aortic aneurysms by the chimney technique.Vascular, pp.3-7.Purpose: to evaluate the use of chimney grafts in the treatment of para-anastomotic aneurysms after previous abdominal aortic aneurysms open repair with short neck.Method: a retrospective analysis of prospectively collected data of consecutive patients who underwent endovascular repair for proximal aortic para-anastomotic aneurysms following previous open repair for infrarenal abdominal aortic aneurysms was performed.Per the article adverse events included occlusion, endoleaks (bleeding).

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 9772447
• MDR Text Key: 190313848
• Report Number: 3011175548-2020-00357
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: No
• 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