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 Embolism (1829); Blood Loss (2597); Vascular Dissection (3160)

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 the gore viabahn vbx balloon-expandable endoprosthesis can be safely used as bridging stent graft for fenestrated or branched endografts.A longer follow-up with a larger case load is necessary in order to validate this preliminary experience.

Event Description

Received an article titled first/preliminary experience of gore viabahn balloon expandable endoprosthesis as bridging stent in fenestrated and branched endovascular aortic repair.Purpose: the aim of this study is to evaluate the preliminary outcomes of the gore viabahn balloon-expandable endoprosthesis (vbx) as bridging stent for fenestrated/branched aortic endograft.Method: between april and june 2018, patients undergoing fenestrated and branched endovascular aortic repair were prospectively collected.Per the article adverse events included dissection, type iii endoleaks, paraplegia, cardiopulmonary events, renal insufficiency, embolic events and access site complications.

• 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: 9656981
• MDR Text Key: 188995159
• Report Number: 3011175548-2020-00216
• 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: 01/24/2020
• 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