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

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Obstruction/Occlusion (2422)

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: marchal, j.E.(2021).Endovascular repair of a ruptured thoracoabdominal aortic aneurysm with the sandwich technique: a case report.Vascular and endovascular surgery, 86-90.Introduction: case report of ruptured thoracoabdominal aortic aneurysm (taaa) in a morbidly obese (b)(6) man.The patient was admitted with a stable hemodynamic state.A computed tomography angiogram (cta) revealed a contained ruptured taaa with an occluded celiac trunk and left renal artery due to previous nephrectomy.Due to the emergency and his comorbidities, an endovascular aortic repair with the sandwich technique and 2 chimneys.Two bridging stents (chimneys) were deployed between the aorta and the target vessels (superior mesenteric and right renal arteries) in a space created in-between 2 aortic straight endografts.Ten days postoperative, acute renal failure appeared and right renal stent occlusion was diagnosed on cta.Unfortunately, no adequate kidney revascularization could be obtained, requiring permanent hemodialysis.At a 3-month follow-up visit, the patient did well with stable aneurysm dimensions.Conclusions: encouraging outcomes of chimney-evar techniques, comparable to those in published reports of fenestrated-evar and branched-evar, support this procedure as a valid off-the-shelf available alternative in emergency situations.Nevertheless, only few midterm results achieved are actually available and long-term outcomes are actually unknown.Per the article adverse event included occlusion right renal artery with resulting renal failure.

Event Description

N/a.

Manufacturer Narrative

Article reviewed marchal, j.E.(2021).Endovascular repair of a ruptured thoracoabdominal aortic aneurysm with the sandwich technique: a case report.Vascular and endovascular surgery, 86-90.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 case report claims encouraging outcomes in emergency situation on morbidly obese patient, however we should consider that the right renal bridging stent graft combined with getinge advanta v12 and gore viabhan self-expandable stents occluded on day ten and patient suffered acute renal failure with no adequate kidney revascularization obtainable, leading to permanent hemodialysis.The exact cause of complete occlusion of the bridging stent to the right renal artery is unknown.The authors do not attribute this vascular event to any particular bridging stent.H3 other text : not available for return.

• 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: 12839885
• MDR Text Key: 282932147
• Report Number: 3011175548-2021-01147
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 11/14/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Male