MAUDE Adverse Event Report: ATRIUM MEDICAL V12 LD; STENT, RENAL

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

Patient Problems Failure of Implant (1924); Pseudoaneurysm (2605)

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 the use of advanta v12 large diameter stent grafts for infrarenal abdominal aortic pseudoaneurysms (due to bd), especially in female patients with small aortic diameter, is safe and efficient.Primary patency rate of the stent grafts at 4 years is excellent.

Event Description

Article received: altay, c.E.(2017).Atrium advanta v12 large diameter stent-graft applications for infrarenal abdominal aortic pseudoaneurysms (due to behcet disease): safety and efficacy.Annals of vascular surgery, 197-202.Purpose: to determine the safety and effectiveness of atrium advanta v12 large diameter stent-graft applications for infrarenal abdominal aortic pseudoaneurysms.Per the article adverse events included 1 patient with recurrence of her pseudoaneurysm.

• Brand Name: V12 LD
• Type of Device: STENT, RENAL
• 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: 7921913
• MDR Text Key: 122163933
• Report Number: 3011175548-2018-01063
• Device Sequence Number: 1
• Product Code: NIN
• 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

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• 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: 09/11/2018
• 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