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

Device Problem Malposition of Device (2616)

Patient Problems Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

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 study concluded the use of f-evar, b-evar, and ch-evar allows effective treatment of postsurgical pararenal aneurysms bases on a clear algorithm and patient selection, highlighting the complementary character of these less invasive approaches.

Event Description

Received an article titled complementary role of fenestrated/branched endografting and the chimney technique in the treatment of pararenal aneurysms after open abdominal aortic repair.The article evaluated the totally endovascular techniques for treating complex pararenal aortic aneurysms after open repair of abdominal aortic aneurysm.Per the article adverse events included: ischemic events (aki), bleeding, stent misplacement, and pseudoaneurysm.

• Brand Name: ADVANTA V12 COVERED STENT
• 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: 8308830
• MDR Text Key: 135136021
• Report Number: 3011175548-2019-00141
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/05/2019
• 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