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

Model Number 85351

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Description of incident: it was reported that an appearance of a marked hypereosinophilic syndrome following implantation of endovascular material to management of an abdominal aortic aneurysm occurred.Hypereosinophilia absent beforehand, appeared from day 9 and plateaued since up to 4g/l with major skin involvement.No frank drug cause, nor parasitic and neoplastic cause.

Manufacturer Narrative

It was reported that patient suffered from an appearance of a marked hypereosinophilic syndrome following implantation of endovascular material (two advanta v12 covered stents, along with three bentley begraft stents) for management of an abdominal aortic aneurysm.Hypereosinophilia was absent beforehand, appeared from day 9 and plateaued since then up to 4g/l with major skin involvement.No frank drug cause, nor parasitic and neoplastic cause.Patient's condition at time of report: chronic hypereosinophilia with severe, disabling eczematous skin involvement.Risk of cardiovascular toxicity if chronic course (aneurysm, thrombosis, intravg thrombus, etc.) the affected device was not returned and no lot/serial numbers were provided.Multiple attempts to obtain additional information about the incident, including whether the patient has been tested for a metal hypersensitivity or nickel allergy, were unanswered.These factors limited the depth of investigation that was possible.A review of complaints received over the past three (3) years shows that there have been no similar reports of eosinophilia or hypereosinophilic syndrome associated with atrium medical covered stents.The advanta v12 covered stent is comprised of 316l stainless steel, encapsulated with expanded polytetrafluoroethylene (eptfe).316l stainless steel alloy typically contains nickel, chromate and molybdenum.The begraft devices that were also implanted are comprised of l605 cobalt chromium (cocr), also encapsulated with eptfe, but only externally (1).L605 cocr is a cobalt-chromium-tungsten-nickel alloy.Both alloys contain approximately 10% nickel.Ptfe is a highly inert material, meaning it is typically accepted by the body with a minimal response from the immune system.Stainless steel and cocr are used in many medical products and are known for their biocompatibility.Atrium medical has evaluated the biological safety of the advanta v12 covered stent as a permanent implant in contact with circulating blood in accordance with iso 10993-1:2009, and it is considered safe and suitable for use as directed.However, the stents do contain nickel.While extremely rare, it is possible to have an allergic reaction to the stent.Symptoms might include: rash, hives, itching, bruising, joint pain or swelling, muscle pain, fevers or any other symptoms of an allergic reaction.The advanta v12 instructions for use (ifu) include the following warning/caution: ¿people with allergies to 316l stainless steel (in particular nickel) or ptfe may suffer an allergic response to this implant.¿ in the literature, several cases have been reported where eosinophilia or other allergic response was observed after stent implantation and attributed to nickel or other metal sensitivity.Nickel allergy is one of the most common allergies and causes of dermatitis in the world, with a reported incidence of 8% to 15% in the general population (2).There have been reported cases of patients with nickel allergy who had a nickel-containing medical implant and suffered from a pronounced systemic response, with clinical findings frequently including eczematous rash (3), as noted in this case.It is also recognized that both cobalt and chromium are common metals that can elicit cutaneous and extracutaneous allergic reactions, including hypereosinophilia, from chronic internal exposure (4,5).After review of the details provided, as well as review of the published clinical literature, that clearly highlights the possible risks and complications known to occur following placement of advanta v12 covered stent, one can infer the unfortunate injuries suffered by this patient are potentially multifactorial and the advanta v12 covered stent was not the only attributing factor.The factors likely include but are not limited to, begraft peripheral stent graft system implantation and patient¿s predisposition to 316l stainless steel (in particular nickel) or ptfe, which triggered a severe allergic response.There is no indication that a device defect or malfunction was the cause of this event.As such, we cannot definitely determine root cause, but have identified likely factors.This event is considered an anticipated procedural complication for persons with a ptfe or nickel sensitivity.This is disclosed in the product labeling.Sources 1.Https://www.Bentley.Global/var/upload/ben409_brochure_begraftperipheral_2019_pages.Pdf 2.Jetty, p, jayaram, s, veinot, j, pratt, m.Superficial femoral artery nitinol stent in a patient with nickel allergy, j vasc surg 2013;58:1388-90.Doi: 10.1016/j.Jvs.2013.01.041.3.Univers j, long c, tonks sa, freeman mb.Systemic hypersensitivity reaction to endovascular stainless steel stent.J vasc surg.2018 feb;67(2):615-617.Doi: 10.1016/j.Jvs.2017.08.085.Epub 2017 dec 13.Pmid: 29248243.4.Basko-plluska jl, thyssen jp, schalock pc.Cutaneous and systemic hypersensitivity reactions to metallic implants.Dermatitis.2011 mar-apr;22(2):65-79.Pmid: 21504692.5.Cadossi m, chiarello e, savarino l, mazzotti a, tedesco g, greco m, giannini s.Fast growing pseudotumour in a hairdresser after metal-on-metal hip resurfacing: a case report.Eur rev med pharmacol sci.2014;18(1 suppl):29-33.Pmid: 24825038.H3 other text : not available for return.

• Brand Name: STENTS ADVANTA V12
• 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: 14278085
• MDR Text Key: 293307762
• Report Number: 3011175548-2022-00137
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85351
• Device Catalogue Number: 85351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BEGRAFT LOT 214094 (1), 213629 (2) AND 206604 (2)
• Patient Outcome(s): Required Intervention