MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENTS; PROSTHESIS, TRACHEAL, EXPANDABLE

Device Problem Insufficient Information (3190)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Article received.Troutman, d.A.(2014).Duplex ultrasound diagnosis of failing stent grafts placed for occlusive disease.Rapid paper session of the 2014 vascular annual meeting of the society for vascular surgery (pp.1580-1584).Boston, massachusetts: society of vascular surgery.Objective: we previously showed that duplex ultrasound (du) imaging is beneficial in the diagnosis of failing vein and prosthetic grafts performed for arterial occlusive disease.The purpose of this study was to evaluate whether du imaging can reliably diagnose failing stent grafts (ie,covered stents) placed for arterial occlusive disease.Method: between july 1, 2005, and june 30, 2013, we placed 142 stent grafts in 92 arterial segments (1.5 stent grafts/stenotic artery) for lower extremity occlusive disease in patients who also underwent at least one du surveillance study documenting a patent stent graft.Conclusions: these findings suggest that follow-up du surveillance can predict failure of stent grafts placed for lower extremity occlusive disease.Focal psvs >300 cm/s, vr >3.0, and most importantly, uniform psvs <50 cm/s throughout the stent graft were statistically reliable markers for predicting stent graft thrombosis.Per the article adverse events included occlusion and thrombosis.

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

N/a.

Manufacturer Narrative

Article reviewed: troutman et al.2014.Duplex ultrasound diagnosis of failing stent grafts placed for occlusive disease.J vasc surg; 60:1580-1584.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: note: the use of the device may be related to an off-label use of the icast¿ balloon expandable covered stent, which means that the use has not been approved or cleared by the food and drug administration (fda) as safe or effective.Getinge¿s icast¿ covered stent is fda 510(k) cleared for the treatment of tracheobronchial strictures produced by malignant neoplasms.The instructions for use clearly states that potential adverse effects of advanta v12 balloon-expandable stent include, but may be not limited to: inadequate implantation or intimal trauma, restenosis of stented lesion, stent misplacement, migration or deformation, systemic embolization or thromboembolic episodes.Although of 20 stent grafts with one or more abnormal du findings, 15 underwent prophylactic intervention or occluded without intervention, whereas only two of 72 stent grafts with normal du findings occluded without intervention, however considering the design of the study with relatively small sample size, variety of arterial beds being compared and wide variety of used stents, one can infer that the getinge¿s icast¿ balloon expandable covered stent performed as expected.The authors did not attribute endovascular complications to any particular stent type.H3 other text : not available for return.

• Brand Name: ICAST COVERED STENTS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 12725041
• MDR Text Key: 281219785
• Report Number: 3011175548-2021-01107
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• 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
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 10/30/2021
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 10/29/2022
• 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