MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 VASCULAR STENTS; STENT, ILLIAC

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

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Necrosis (1971); Occlusion (1984); Paralysis (1997); Renal Failure (2041)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.The article concluded that osr appears to be the most appropriate first-line treatment for jaaa in good risk patients; however, evar may represent an alternative option in high risk patients.[(b)(4)].

Event Description

Article received: maeda, k.E.(2017).Comparison between open and endovascular repair for the treatment of juxtarenal abdominal aortic aneurysms: a single-center experience with midterm results.Annals of vascular surgery, 96 - 104.Purpose: to evaluate optimal treatment for juxtarenal abdominal aortic aneurysm (jaaa).Per the article adverse events included endoleaks, myocardial infarction, paraparesis, bowel necrosis, cholesterol crystal embolization, acute renal failure with hemodialysis and renal artery occlusion.

• Brand Name: ADVANTA V12 VASCULAR STENTS
• Type of Device: STENT, ILLIAC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7921905
• MDR Text Key: 122164013
• Report Number: 3011175548-2018-01071
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• 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: 10/01/2018

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: 09/14/2018
• Initial Date FDA Received: 10/01/2018
• 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