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

Device Problem Insufficient Information (3190)

Patient Problems Ruptured Aneurysm (4436); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: gennai, s.E.(2021).Bridging stent-graft fracture after branched endovascular aortic repair in a dual-center retrospective cohort study.Journal of vascular surgery.Objective: target vessel instability is a relevant complication after thoracoabdominal aortic aneurysms branched endovascular aortic repair (bevar).Long-term bridging stent-graft (bsg) durability has already been established, but the incidence of long-term complications as component fractures was not deeply investigated.This paper aims to assess bsg fracture incidence and risk factors after bevar.Method: this was a dual-center observational retrospective cohort study.Data of each patient treated with bevar between april 2008 and december 2019 were prospectively collected.Conclusions: bsg fracture is a rare but severe complication after bevar.It is not related to the stent type used as bridging stent, and it is hardly predictable based on preoperative anatomy.Using multiple and different stents on the same vessel and relining the bridging stents with bare-metal stents may increase bsg fracture risk.A strict computed tomography angiography follow-up remains the best strategy to detect target vessel instability.Per the article adverse events included progression of disease, thrombus, renal failure, aneurysm rupture.

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: although considering the dual-center retrospective observational cohort study design, high technical success rate and very low number of fractures detected, one can infer that getinge advanta v12 stent performed as expected, however bridging stent-graft fracture is a rare but severe complication after branched endovascular aneurysm repair leading to type iiib endoleak.It is important to know that bridging stent-graft durability not related to the stent type used as bridging stent, and it is hardly predictable based on preoperative anatomy.According to the report the advanta v12 stents were successfully relined during secondary intervention.The author did not report any major adverse patient effects as result of this event.

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: 12800254
• MDR Text Key: 284185551
• Report Number: 3011175548-2021-01120
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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: 05/19/2022
• 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