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

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

Patient Problems Aneurysm (1708); Occlusion (1984); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Article received: keschenau, p.E.(2020).Management strategies for true and dissecting visceral artery aneurysms.The journal of cardiovascular surgery, 340-306.Purpose: to evaluate a 13-year experience with visceral artery aneurysms (vaa) treatment including conservative, open surgical and endovascular therapy.Method: this retrospective single-center study included 37 patients treated for vaa between january 2006 and december 2018.Per the article adverse events included: type i endoleak, occlusion, aneurysm recurrence and aneurysm progression.

Manufacturer Narrative

Per the article adverse events included: type i endoleak, occlusion, aneurysm recurrence and aneurysm progression.The article is specific to visceral artery aneurysms.The locations cited in the article were the mesenteric artery, the splenic artery and the celiac trunk.The article is specific in regards to the use of the v12 in regards to the use for aneurysmal exclusion.The advanta v12 covered stent system is indicated for restoring and improving the patency of the iliac and renal arteries.Renal approval includes 5mm, 6mm and 7mm diameter advanta v12 sizes.Atrium medical has not tested or evaluated the use of the v12 covered stent in the mesenteric artery, the splenic artery or the celiac trunk or as an aneurysmal exclusion device.The complications cited included type i endoleak, occlusion, aneurysm recurrence and aneurysm progression.These complications cannot be directly related to the performance of the advanta v12 covered stent as the operative techniques as well as patient conditions contribute to the complications.There were no part numbers or product lot numbers provided.Based on the lack of details and the inability to obtain any additional information it cannot be confirmed that the v12 device was the cause of the complications observed during the study.H3 other text : product not available.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11042090
• MDR Text Key: 222627699
• Report Number: 3011175548-2020-01462
• Device Sequence Number: 1
• Product Code: NIO
• 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,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention