MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 VASCULAR STENTS; STENT, RENAL

Device Problem Output Problem (3005)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.The article concluded ¿real world¿ feasibility of the fenestrated anaconda stent graft is demonstrated with 4% perioperative mortality.Limb thrombosis during follow up is of concern.

Event Description

Article: shahverdyan, r.E.(2016).Single centre results of total endovascular repair of complex aortic aneurysms with custom made anaconda fenestrated stent grafts.European journal of vascular and endovascular surgery, 500-508.Purpose: to report experience using the anaconda fenestrated device with special emphasis on target vessel patency and pitfalls with the device.Per the article deaths occurred within the study period.

• Brand Name: ADVANTA V12 VASCULAR STENTS
• Type of Device: STENT, RENAL
• 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: 7942818
• MDR Text Key: 123050362
• Report Number: 3011175548-2018-01110
• Device Sequence Number: 1
• Product Code: NIN
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• 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: 09/24/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death