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

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

Patient Problems Ischemia (1942); Occlusion (1984); Stenosis (2263)

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 outcomes in terms of mortality and major adverse events after f/b-evar were good.Rate of branch instability and reinterventions was high, with a clear connection to fractured begrafts.Device not returned.

Event Description

Received an article titled outcome after fenestrated and branched repair of aortic aneurysms - device failures predict reintervention rates.Purpose: our aim was to analyze our outcome after f/b-evar of complex abdominal aortic aneurysms and thoracoabdominal aneurysms.Method: single-center, retrospective cohort study, of all consecutive f/b-evar between aug 2009 and dec 2018.Per the article adverse events included ischemia, occlusion and restenosis.

• Brand Name: ADVANA 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: 9657017
• MDR Text Key: 190830986
• Report Number: 3011175548-2020-00231
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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