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 Ischemia (1942); Renal Failure (2041); Respiratory Failure (2484); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: eleshra, a.E.(2020).Short-term outcomes of the t-branch off-the-shelf multibranched stent graft for reintervention after previous infrarenal aortic repair.Journal of vascular surgery, 1-9.Purpose: the purpose of this study was to evaluate the outcome of t-branch (cook medical) stent graft for the treatment of thoracoabdominal and pararenal aortic aneurysms in patients who had previous infrarenal aortic repair.Method: a retrospective two-center study was undertaken.All consecutive patients who underwent endovascular repair using t-branch stent graft after previous infrarenal aortic repair between january 2010 and august 2018 were included.Conclusion: the use of t-branch off-the-shelf stent graft for the treatment of aortic disease in patients who had previous infrarenal aortic repair appears to be feasible, with acceptable early outcomes in terms of morbidity and mortality.Per the article adverse events included: endoleak, blood loss, acute renal injury, new onset dialysis, ischemic events and respiratory failure.

Manufacturer Narrative

This complaint is based on information within an article and no specific device information has been provided.As there is insufficient details of an actual device malfunction or adverse event that occurred the complaint cannot be confirmed.Conclusion: considering the retrospective observational design of the study, excellent technical success results of 97% despite a high percentage (28%) of patients with urgent presentation and high patency rates of the bridging stents and their targeted vessels, one can infer that getinge¿s advanta v12 stents performed as expected.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
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 11356614
• MDR Text Key: 232791520
• Report Number: 3011175548-2021-00198
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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: 02/08/2021
• Initial Date FDA Received: 02/21/2021
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 06/30/2022
• 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