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 Seroma (2069); Pseudoaneurysm (2605); Vascular Dissection (3160)

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 implantation of ibd devices for the treatment of hypogastric artery aneurysms shows good technical results with a high primary patency and a low rate of perioperative complications.Device not returned.

Event Description

Received an article titled endovascular treatment of hypogastric artery aneurysms.Purpose: the aim of this study was to evaluate the treatment possibilities in an era of advanced endovascular techniques and their potential to preserve iliac blood flow while reliably excluding the aneurysm.Method: a retrospective analysis of 46 consecutive patients with endovascularly treated iiaa was performed.Data were collected from a single-institution aortoiliac database.Between september 2009 and may 2016, a total of 46 patients with 55 iiaas were identified.Per the article adverse events included ischemia, pseudoaneurysm, seroma, infection, dissection and occlusion.

• 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: 9656978
• MDR Text Key: 188510447
• Report Number: 3011175548-2020-00208
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 01/23/2020
• 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