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

Device Problem Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Received an article: karelis, a.E.(2020).The use of iliac branched devices in the acute endovascular repair of ruptured aortoiliac aneurysms.Annals of vascular surgery, 171-177.Purpose: to evaluate the feasibility and midterm outcomes of iliac branch devices (ibds) to preserve the internal iliac artery perfusion in emergent endovascular repair of ruptured aorto-iliac aneurysms.Method: between december 2012 and july 2017, a total of 8 ibds were implanted in 6 patients in a single tertiary referral center.Conclusion: the use of ibds in the acute setting is feasible to exclude ruptured aortoiliac aneurysms while maintaining pelvic circulation.Per the article product problems included stent-graft kink (deformation).

Event Description

N/a.

Manufacturer Narrative

Article reviewed: karelis et al.2020.The use of iliac branched devices in the acute endovascular repair of ruptured aortoiliac aneurysms.Ann vasc surg; 67:171-177.The subject article is a single-center retrospective review of 6 patients who underwent repair of ruptured abdominal aortic aneurysm with a concomitant common iliac artery aneurysm or isolated common iliac artery aneurysm (cia) aneurysms between december 2012 and july 2017, a total of 8 iliac branch devices (ibds) were implanted.The objective of this study was to evaluate the feasibility and midterm outcomes of ibds to preserve the internal iliac artery perfusion in emergent endovascular repair of ruptured aorto-iliac aneurysms.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.Considering the design of the study and small sample size, that technical success was achieved in all cases, there were no deaths during the follow-up and no major complications unrelated to the ibd, the freedom from reintervention estimate was 75% through 2 years, the overall primary assisted patency was 100% through 3 years and the fact that the secondary clinical success was achieved in all cases, one can infer that the getinge¿s advanta v12 balloon expandable covered stents performed as expected.H3 other text : product not returned.

• 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: 11485793
• MDR Text Key: 241927185
• Report Number: 3011175548-2021-00321
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• 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