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); Occlusion (1984); Renal Disease, End Stage (2039)

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 there are potential advantages to cg-evar with off the shelf availability, versatility, and low profile devices.

Event Description

Article received: caradu, c.E.(2017).Monocentric evaluation of chimney versus fenestrated endovascular aortic repair for juxtarenal abdominal aortic aneurysm.Annals of vascular surgery, 28-38.Purpose: to report the midterm results of cg-evar in a single center with standardized methods and to compare them to f-evar.Per the article adverse events included unable to deliver related to patients anatomy, type ia endoleaks, type ii endoleaks, occlusion, acute kidney injury and chronic kidney disease.

• 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: 7921910
• MDR Text Key: 122165549
• Report Number: 3011175548-2018-01075
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

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