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

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

Patient Problems Occlusion (1984); Rupture (2208); 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.The article concluded that a tailor-made ibd is an easy-to-apply, alternative option for preserving the iia perfusion in short ciaa patients with and without aaa.

Event Description

Received an article titled tailor-made iliac branched device for preserving the internal iliac artery in patients with common iliac artery aneurysm.Purpose: we report our medium-term results of using tailor-made ibd for patients with short common iliac artery (cia) with and without abdominal aortic aneurysm (aaa).Method: a retrospective review of 10 consecutive patients who had received the tailor-made ibd for short ciaa or type ib endoleak between march 2013 and march 2017 was conducted.Per the article adverse events included occlusion, aneurysm rupture and endoleaks.

• Brand Name: ADVANTA V12 COVERED STENT SYSTEM
• 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: lynda mclaughlin ; 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 9656993
• MDR Text Key: 190309263
• Report Number: 3011175548-2020-00223
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2020
• 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: 01/27/2020
• 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