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

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

Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Pneumonia (2011)

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 pmsgs provided acceptable short term results and may be a management option for the treatment of taaa in selected high risk patients.[(b)(4)].

Event Description

Article: cochennec, f.E.(2015).Early results of physician modified fenestrated stent grafts for the treatment of thoraco-abdominal aortic aneurysms.European journal of vascular and endovascular surgery, 583-592.Purpose: to determine whether physician modified stent grafts (pmsgs) are safe and effective for the treatment of high risk patients with thoraco-abdominal aortic aneurysms (taaas).Per the article adverse events included ischemic events, hemorrhage, pneumonia and prostatitis.

• 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: 7942819
• MDR Text Key: 123057996
• Report Number: 3011175548-2018-01128
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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?: 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