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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ischemia (1942); Occlusion (1984); 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 study concluded the use of ch-evar in treating complex aortic aneurysms is technically feasible and safe.

Event Description

Received an article titled: parallel stent grafts for the treatment of complex aortic aneurysms: a single center study.The article reported a single center experience using ch-evar in treating complex aortic pathologies.Per the article adverse events included: dislodgement, bleeding, ischemia, and occlusion.

• Brand Name: ADVANTA V12 COVERED STENT
• 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: 8326233
• MDR Text Key: 135735453
• Report Number: 3011175548-2019-00119
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/11/2019
• 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