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

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

Patient Problem Stenosis (2263)

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 procedure was shown to be safe for kidney function, feasible to exclude the aneurysmatic sac and to restore vessel patency.

Event Description

Article: gandini, r.E.(2015).Long term follow up of endovascular treatment of renal artery aneurysms with covered stent deployment.European society of radiology.Purpose: to examine feasibility, effectiveness and results of treatment of the renal artery aneurysms positioned in the main artery using covered stents.Per the article adverse events included 1 patient where the advanta v12 was deployed, a restricted area (restenosis) on superior pole of the right kidney characterized by an absent contrast enhancement was observed at 6 month follow up probably caused by suspension of the after procedural double anti aggregation therapy.

• 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: 7942812
• MDR Text Key: 123059958
• Report Number: 3011175548-2018-01108
• 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
• 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
• Device Age: YR
• 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
• Patient Age: 31 YR