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); Occlusion (1984); Thrombosis (2100); 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 article concluded the fenestrated anaconda stent graft system offers acceptable technical success rates, midterm efficacy and durability with respect to aneurysm sac regression, target vessel patency, overall mortality and re-intervention rates.

Event Description

Article received: midy, d.E.(2017).Results of the french multicentric study of anaconda fenestrated endografts in the treatment of complex aortic pathologies (efefa registry).Annals of vascular surgery, 151-165.Purpose: to assess the midterm results in the treatment of complex aortic aneurysms.Per the article adverse events included endoleaks, occlusion, ischemia, thrombosis and pseudoaneurysm.

• 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: 7921953
• MDR Text Key: 122167084
• Report Number: 3011175548-2018-01087
• 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: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• 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: 09/11/2018
• 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