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

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Death  

Event Description

Article received: bjoern, s.E.(2021).Management and endovascular therapy of ureteroarterial fistulas: experience from a single center and review of the literature.Cvir endovascular, 1-13.Objective: ureteroarterial fistula (uaf) is a rare but potentially life threatening disease.The aim of this study was to evaluate the outcome of endovascular therapy for uaf.Treatment.Method: this retrospective case series evaluates a single center experience of percutaneous stent graft (sg) angioplasty and/or coil embolization for uaf.Patient follow-up included technical and early clinical success, complications and revisional procedures.We also conducted a systematic review of the literature reporting on endovascular uaf management.Conclusions: endovascular therapy offers high technical success rates and rapid bleeding control of uaf.Severe complications like sg occlusions or sg infections are rare but significant.Antibiotic treatment and single antiplatelet therapy improve sg durability as well as close and long follow-up to timely perform repeated endovascular or surgical treatment if necessary.Per the article deaths occurred due to recurrent hemorrhage.

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.Not available for return.

Manufacturer Narrative

Article reviewed: simon, et al.(2021).Management and endovascular therapy of ureteroarterial fistulas: experience from a single center and review of the literature.Cvir endovascular 4:36.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: although this retrospective cohort study incudes patients who typically carry a high risk for complications due to previous extensive surgery and radiation therapy which lead to adhesions, fibrosis, and frail tissue, however endovascular therapy offers high technical and early clinical success rates.Stent thrombosis is one important post interventional complication: in this study cohort authors observed sg thrombosis in 17.7% of the cases in opposition to 5% in literature review.The authors do not attribute those vascular events to any particular stent.After review of the details provided, one can infer that getinge¿s advanta v12 stent performed as expected and the major risk factors for developing stent thrombosis were underlying vasculopathy or advanced tumor disease with extrinsic stenosis of iliac vessels since all three patients who developed sg thrombosis had a history of pelvic malignancy with previous surgery and radiotherapy, one of them also had advanced peripheral artery disease.

• 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: 12843670
• MDR Text Key: 281009766
• Report Number: 3011175548-2021-01123
• 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,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death