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

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

Patient Problems Embolism (1829); Ischemia (1942); Occlusion (1984); Thrombus (2101)

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 evpar seems a safe and efficacious treatment option in selected patients.

Event Description

Received an article titled endovascular treatment of chronic occluded popliteal artery aneurysm: early and mid-term outcomes.Purpose: to review an experience of endovascular popliteal aneurysm repair (evpar) in patients with chronic occluded popliteal artery aneurysm (paa).Method: a retrospective study from (b)(6) 2011 to (b)(6) 2015 of 25 patients.Per the article adverse events included: ischemia, occlusion, embolic events and thrombus.

Manufacturer Narrative

Corrected manufacturer aware date (b)(6)2019.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILLIAC
• 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: 8280181
• MDR Text Key: 134181942
• Report Number: 3011175548-2019-00099
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 01/25/2019

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: 01/23/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 02/11/2019
• 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