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

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article: moalong, k.E.(2020).Fip1l1-pdgfra - positive hypereosinophilia presenting with bilateral extracranial carotid artery aneurysms.World neurosurgery, 419-422.Purpose: to describe a case of an adult female filipino with hypereosinophilia and bilateral carotid artery aneurysms who subsequently developed bilateral cerebral hemisphere strokes following aneurysm stenting.Method: a case study.Conclusion: this case demonstrates a possible and heretofore undocumented neurovascular sequela of hypereosinophilic syndrome.Per the article adverse events included cerebral infarction.

Manufacturer Narrative

Based on the article received the patient was an adult female with hypereosinophilia and bilateral carotid artery aneurysms who subsequently developed bilateral cerebral hemisphere strokes following aneurysm stenting.Per the article product problems included stent migration.A review of the article received indicates that two advanta v12 6mm x 59mm stents were implanted in the patients carotid artery to isolate an extremely large aneurism.The two stents were overlapped to span the length of the aneurism.The details mention that the initial deployment was successful an angiogram was done to confirm adequate placement of the stents and excluded any endovascular leaks.None were noted in the article.The article then states: "an open procedure with the goal of decreasing the aneurysm size with thrombus removal and aneurysm wall biopsy was attempted.However, during this maneuver, the installed stents were inadvertently displaced, resulting in recurrent filling of the aneurysm in a subsequent angiogram.A balloon was brought up into the stent and inflated to improve apposition to the vessel wall.A repeat angiogram confirmed the absence of an endovascular leak.The plan for thrombus removal and vessel wall biopsy was aborted".In this regard the stent migration was noted by the physician to have been inadvertently displaced while conducting an open surgical biopsy and not because of the performance of the advanta v12 stents that were implanted.The details describe that the stents were post dilated again to improve apposition to the vessel wall and a repeat angiogram confirmed the absence of an endovascular leak.Based on the article there is no indication that there was an adverse event caused by the placement of two advanta v12 6mm x59mm covered stents.The article also states that the patient also had a stroke associated with the procedure.The physician in the discussion section of the article implies that the reason for the stroke was the following: "a review on the treatment of extracranial carotid artery aneurysms found an advantage to treating these aneurysms in terms of stroke and mortality.Indications for surgery include large aneurysm size, mural thrombus, aneurysm growth, thromboembolic events, and rupture.Given the aneurysm size (51 mm) and presence of a 16 mm mural thrombus in our patient, we felt that a stenting procedure was warranted for primary stroke prevention.The occurrence of contralateral ischemic stroke immediately following carotid artery stent placement is rare but has been reported.We believe this complication in our case is likely from aneurysm thrombus disruption and subsequent embolization." based on the details of the complaint the article does not imply at any point that the advanta v12 was deficient in any way and therefore cannot confirm that the product was deficient.The root cause in the regard is considered operational context as this is considered an off label application of the device.The advanta v12 has not been tested or evaluated for the use of the device in the carotid artery nor has it been evaluated or tested as an aneurism exclusion device.The indications for use of the advanta v12 as stated in the instructions for use aw011498 revision aa are the following: indications the advanta v12 covered stent system is indicated for restoring and improving the patency of the iliac and renal arteries.Renal approval includes 5mm, 6mm and 7mm diameter advanta v12 sizes.In canada, the advanta v12 covered stent system indication excludes renal arteries.H3 other text: device not available for return.

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: 11485783
• MDR Text Key: 239817332
• Report Number: 3011175548-2021-00313
• 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: 05/03/2022

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?: 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: 04/26/2022
• 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: 57 YR
• Patient Sex: Female