MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 VASCULAR STENTS; STENT, ILLIAC

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Respiratory Failure (2484); Multiple Organ Failure (3261); Cancer (3262)

Event Type  Death  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the article the endovascular repair of taaa by using cook zenith fenestrated/branched endografts is feasible with acceptable technical and clinical results at early to mid-term results in patients at high surgical risk unfit for or.

Event Description

Article received: gallitto, e.E.(2017).Endovascular repair of thoracoabdominal aortic aneurysm in high surgical risk patients: fenestrated and branched patients.Annals of vascular surgery, 170-177.Purpose:to report early and mid-term results of endovascular repair of thoracoabdominal aortic aneurysms (taaa) by using cook zenith fenestrated/branched endograftes (fb-evar) in high surgical risk patients unfit for open repair.Per the article deaths occurred during the study period: respiratory failure; multiorgan failure; cardiac failure; cancer.

• 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: 7921909
• MDR Text Key: 122166897
• Report Number: 3011175548-2018-01074
• Device Sequence Number: 1
• Product Code: NIO
• 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?: 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: 09/14/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death