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

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

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Thromboembolism (2654)

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 this is a reproducible adjunct to staged taaa endovascular repair.The use of a bare branch instead of a branch left completely open has the clear advantage of an easy catheterization in the second step.Furthermore, by having the target vessel stented with a bare stent, the risk of embolism is avoided.In this experience, there was no significant aneurysm sac growth in between the steps.

Event Description

Received an article titled the 'bare branch' for safe spinal cord ischemia prevention after total endovascular repair of thoracoabdominal aneurysms.Journal of vascular surgery, pp.1655-1663.Purpose: we here present the ¿bare branch¿ technique, a safe adjunct to taaa repair in terms of interstage complications.Method: in the first step, one branch, preferentially the one for the celiac trunk, is stented by a bare stent; in the second step, the bare branch is relined with a covered stent.There were 32 taaas treated by this approach at our center from january 2015 to december 2017.Data were prospectively collected and retrospectively analyzed.Per the article adverse events included blood loss, thromboembolic events, hematoma, renal injury and hemodynamic instability.

• Brand Name: ADVANTA 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: 9657001
• MDR Text Key: 190306853
• Report Number: 3011175548-2020-00214
• 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: 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