MAUDE Adverse Event Report: ATRIUM MEDICAL CORPROATION ADVANTA V12 COVERED STENT; PTFE COVERED STENT

Device Problem Kinked (1339)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Questions were sent to the author of the article.Author responded that no further information is available.The article concluded that the use of the nellix endoprosthesis combined with chimney grafts is technically feasible.Associated file: 3011175548-2017-00080 - (b)(4).

Event Description

Received an article titled: endovascular aneurysm sealing for juxtarenal aneurysm using the nellix device and chimney covered stents published in the journal of endovascular therapy.Objective: to look at the nellix endoprosthesis in as a solution to the limitations of conventional evar, specifically, migration and endoleaks.Two case studies that were unsuitable for open surgery as well as fenestrated stent-graft.They were both treated with chimney grafts and nellix endoprosthesis.Per the article, procedural complications including one (b)(6) yo male with a complex cardiac history, including mi, afib, and av node re-entry tachycardia.Cta showed minor dissection of the aorta near the renal arteries.Both renal arteries were atherosclerotic with calcifications.The aneurysm treatment was successful.Slight kinking was noted of the left renal stent with no flow limitation.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPROATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPROATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: lynda mclaughlin rn, bsn,ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6815049
• MDR Text Key: 83468470
• Report Number: 3011175548-2017-00079
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 81 YR