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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received an article: lopes, a.E.(2020).An original bailout solution for renal artery dissection after fenestrated/branched evar.Annals of vascular surgery, 286.E1-286.E4.Purpose: to report the use of kissing coronary stents in the renal bifurcation as a bailout solution for dissection after fenestrated/branched endovascular aortic repair method: a case study conclusion: the use of coronary stents was a safe and long-lasting solution to rescue in iatrogenic renal artery dissection during f/b-evar per the article adverse events included occlusion and dissection.

Manufacturer Narrative

Article reviewed: lopes, et al.2020.An original bailout solution for renal artery dissection after fenestrated/branched evar.Ann vasc surg; 65:286 e1-e4.The subject article is a case report of 73-year-old male with an asymptomatic crawford type 4 thoracoabdominal aneurysm and a concomitant right common iliac artery aneurysm was proposed for endovascular repair, consisting of thoracic endovascular aortic repair plus custom-made device f/b-evar, followed by staged bifurcated evar plus right-sided ibd.Renal artery (ra) dissection may occur during endovascular treatment of thoracoabdominal aneurysms.The aim of this paper is to report the use of kissing coronary stents in the renal bifurcation as a bailout solution for dissection after fenestrated/branched endovascular aortic repair (f/b-evar).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: 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 occlusion of the lra was observed and required reintervention, however this effect was attributed to an iatrogenic dissection.Considering the study design and the fact that at 1 year follow-up lra maintained normal patency, one can infer that the getinge¿s advanta v12 balloon expandable covered bridging stents performed as expected.H3 other text : 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: 11388245
• MDR Text Key: 233964419
• Report Number: 3011175548-2021-00231
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 11/16/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male