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

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Occlusion (1984); 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 ch-evar procedure is a suitable option for those patient with multiple comorbidities that are not candidates for open surgical repair.[(b)(4)].

Event Description

Article: stenson, k.E.(2016).Extended use of endovascular aneurysm sealing: chimneys for juxtarenal aneurysms.Seminars in vascular surgery, 120-125.Purpose: to present a technique using parallel grafts.Per the article adverse events included ischemic events, endoleaks, restenosis and occlusion.

• 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: 7942805
• MDR Text Key: 123058995
• Report Number: 3011175548-2018-01115
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

• 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: 09/24/2018
• Initial Date FDA Received: 10/08/2018
• 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