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 Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: senemaud, j.N.(2019).Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms.Journal of vascular surgery, 1834-1842.Purpose: the aim of this study was to describe in-hospital outcomes of custommade fenestrated stent grafts (cmsgs) and pmsgs for the treatment of caaas and thoracoabdominal aortic aneurysms (taaas).Method: in this single-center, retrospective study, all consecutives patients with caaas or taaas undergoing endovascular repair using zenith cmsgs (cook medical, bloomington, ind) or pmsgs between january 2012 and november 2017 were included.Conclusion: our study showed clinically relevant differences of several important in-hospital outcomes in the cmsg and pmsg groups.Per the article adverse events included: rupture, target loss, vascular injury, cannulation failure, jailing of artery and access site complications.

Event Description

N/a.

Manufacturer Narrative

Article reviewed: senemaud, et al.(2020).Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms.J vasc surg; 71:1834-42.The subject article is single-center, retrospective cohort study of all consecutive patients with complex abdominal aortic aneurysms (caaas) or aortic aneurysms (taaas) undergoing endovascular repair using zenith custom made fenestrated stent grafts (cmsgs) (cook medical, bloomington, in) or physician-modified fenestrated stent grafts (pmsgs) between january 2012 and november 2017.End points were intraoperative adverse events, in-hospital mortality, postoperative complications, reinterventions, target vessel patency and endoleaks.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: restenosis of stented lesion, stent misplacement, migration or deformation, short-term hemodynamic deterioration, systemic embolization or thromboembolic episodes, and vascular thrombosis.Although no direct comparison should be made, rates of intraoperative adverse events, mortality, complications, and reinterventions in the pmsg group were two to three times those of the cmsg group.This may be explained by the fact that patients in the pmsg group were more fragile, with more extended aneurysms.After review of the details provided, that clearly highlights the possible risks and complications known to occur following advanta v12tm balloon expandable covered stent implantation, one can infer the unfortunate injuries suffered by study patients are potentially multifactorial and a getinge¿s advanta v12tm balloon expandable covered stents were not the only attributing factor.The factors likely include but are not limited to, the high risk patient¿s with extensive or symptomatic aneurysms requiring rapid treatment, anatomically complex lesions, comorbidities and heterogeneity in selection of patients.The authors do not attribute occurred adverse events to any particular stent type.H3 other text : not available for return.

• 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: 11355965
• MDR Text Key: 232790479
• Report Number: 3011175548-2021-00191
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

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: 02/08/2021
• Initial Date FDA Received: 02/20/2021
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/17/2022
• 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