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 Death (1802); Respiratory Failure (2484)

Event Type  Death  

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 the off the shelf multibranched endograft is a safe and effective therapeutic option for urgent total endovascular taaa repair for which a custom-made endograft is not obtainable in due time.

Event Description

Article received: gallitto, e.E.(2017).Off the shelf multibranched endograft for urgent endovascular repair of thoracoabdominal aortic aneurysms.Journal of vascular surgery, 696-704.Purpose: to report early and midterm results of endovascular repair of urgent thoracoabdominal aortic aneurysms (taaas) by the off the shelf multibranched zenith t-branch endograft.Per the article deaths occurred during the study period respiratory failure and perioperative cardiopulmonary complications.

• 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: 7921914
• MDR Text Key: 122163949
• Report Number: 3011175548-2018-01070
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/01/2018
• 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): Death