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

Device Problem Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Received an article: pini, r.E.(2019).The different effect of branches and fenestrations on early and long-term visceral vessel patency in complex aortic endovascular repair.Journal of vascular surgery, 1128-1134.Purpose: to evaluate the visceral vessel (vv) loss (vvl) according to the type of revascularization performed (fenestrations vs branched) and the necessity for adjunctive visceral procedures (avps).Method: from 2012 to 2017, all f/bevar procedures for juxtarenal abdominal aortic aneurysms (jaaas), pararenal abdominal aortic aneurysms (paaas), and thoracoabdominal aortic aneurrsms (taaas) were considered.Conclusion: early and late vvl was infrequent in complex aortic procedures but seemed to occur more frequently in branches than in fenestration, especially for renal arteries.Per the article product problems included kinking (deformation).

Manufacturer Narrative

Article reviewed: pini et al.2020.The different effect of branches and fenestrations on early and long-term visceral vessel patency in complex aortic endovascular repair.J vasc surg; 71:1128-1134.The subject article is a single-center retrospective review of 158 prospectively collected patients who underwent f/bevar procedures for juxtarenal abdominal aortic aneurysms (jaaas), pararenal abdominal aortic aneurysms (paaas), and thoracoabdominal aortic aneurysms (taaas) between 2012 and 2017.This complaint is based on information found within a article/literature review.There was no product that was available for evaluation, therefore a device evaluation could not be conducted and the complaint cannot be confirmed.The author of the article did not report any major adverse patient effects as result of this event.A device history record (dhr) review was unable to be performed as the device product part number and lot number was not provided within the article.Attempts to obtain the device lot information was conducted but unsuccessful.The hazardous situation/harm is addressed in the risk file and is operating within its risk profile.There was no evidence within the article that the device was the cause of the reported event.The complaint history review did not identify an adverse trend, therefore no escalation to capa process is required.Conclusion: the instructions for use clearly states that potential adverse effects of advanta v12 balloon-expandable stent include, but may be not limited to: inadequate implantation or intimal trauma, restenosis of stented lesion, stent misplacement, migration or deformation, systemic embolization or thromboembolic episodes.Although perioperative vvl occurred in 20 patients (3.8%), 11 cases of vvl had resulted from cannulation failure of five celiac trunks, 2 patients experienced vv dissection in renal arteries, 3 patients experienced vv stenosis and 3 patients had renal artery bleedings, however considering the design of the study, heterogeneous aortic pathology, and the fact that despite the complexity of the procedures, overall vvl was low at 3.8% and significant vvl difference between the branches and fenestrations was identified selectively only for the renal arteries, one can infer that the getinge¿s advanta v12 balloon expandable covered stents performed as expected.H3 other text : product not returned.

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: 11485868
• MDR Text Key: 241927260
• Report Number: 3011175548-2021-00308
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention