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 Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Manufacturer Narrative

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

Event Description

Received an article: chassin-trubert, l.E.(2019).Midterm follow-up of fenestrated and scalloped physician modified endovascular grafts for zone 2 tevar.Journal of endovascular therapy, 377-384.Purpose: to investigate the midterm outcomes of scalloped or fenestrated physician modified endovascular grafts for zone 2 thoracic endovascular aortic repairs.Method: between nov 2013 and may 2019, 54 consecutive patients were treated with thoracic pmegs modified with scallops and fenestrations for the left subclavian artery.Conclusion: scalloped or single fenestrated pmegs for the lsa appear to be durable and safe in the midterm.Per the article deaths occurred within the study period.

Manufacturer Narrative

Article reviewed: chassin-trubert et al.2020.Midterm follow-up of fenestrated and scalloped physician-modified endovascular grafts for zone 2 tevar.J endovasc ther; 27(3):377-384.The subject article is a two centers retrospective cohort study of 54 consecutive patients (mean age 63 years; 41 men) who were treated with thoracic fenestrated physician-modified endovascular grafts (pmegs) modified with 7 scallops or 47 fenestrations for the left subclavian artery (lsa) between november 2013 and may 2019.The purpose of the study was to investigate the midterm outcomes of scalloped or fenestrated physician-modified endovascular grafts (pmegs) for zone 2 thoracic endovascular aortic repairs (tevar).This complaint is based on information found within an 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 four of the lsa fenestrations were unstented, 3 (6%) lsas were unintentionally covered, 2 patients developed a type ii endoleak and required distal extension of covered lsa stents, one patient suffered spinal cord ischemia with irreversible bilateral paraplegia, however considering the study design, high technical success rate 94% and the fact that all the lsas remained clinically and radiologically patent and there were no conversions to open repair, ruptures, retrograde dissection, stent fracture, migrations, or other aortic complications, one can infer that the getinge¿s advanta v12 balloon expandable covered 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: 11517520
• MDR Text Key: 240738683
• Report Number: 3011175548-2021-00334
• 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: 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: 02/22/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 10/27/2022
• 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): Death