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

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

Patient Problems Infarction, Cerebral (1771); Occlusion (1984); Rupture (2208); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not performed as no product code, lot number, or sample was provided.Questions were sent to the author of the article.No response was received.The study concluded that standard use of the endurant abdominal device for ch-evar in >120 patients is associated with high technical success, significant aneurysm sac regression, and low incidence of secondary procedures after 2-year radiologic follow-up.(b)(6).

Event Description

Received an article titled: the protagoras study to evaluate the performance of the endurant stent graft for patients with pararenal pathologic processes treated by the chimney / snorkel endovascular technique published in the journal of vascular surgery, 63(1), pp.1-7.The aim of this study was the midterm evaluation of the endurant stent graft as a standard abdominal device for chimney endovascular aneurysm repair (ch-evar).Between january 2009 and january 2013 , collected data of 128 patients with pararenal pathologic processes who underwent ch-evar with placement of the endurant abdominal device were analyzed.Per the article, procedural complications included adverse events associated with the procedure and follow up.

• 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: 6814861
• MDR Text Key: 83467831
• Report Number: 3011175548-2017-00058
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• 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