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

Article received: d'oria, m.(2019).Secondary endovascular repair of recurring lesions and perioperative complications after open aortic repair: the complementary role of different technical solutions.Annals of vascular surgery, 99-107.Purpose: to describe the complementary role of different technical solutions for secondary endovascular repair of recurring lesions and perioperative complications after open aortic repair (oar).Method: an analysis all consecutive patients who presented recurring lesions and perioperative complications after oar between jan 2015 and jun2018.Conclusion: secondary endovascular repair of recurring lesions and perioperative complications after oar is safe and feasible and offers a minimally invasive effective treatment option.Per the article deaths occurred within the study period.

Manufacturer Narrative

Article reviewed: d¿oria et al.2020.Secondary endovascular repair of recurring lesions and perioperative complications after open aortic repair: the complementary role of different technical solutions.Ann vasc surg; 63:99-107.The subject article is a single-center retrospective cohort study of six consecutive patients who presented with recurring lesions and perioperative complications after open aortic repair (oar) and underwent secondary endovascular repair between (b)(6), 2015 and (b)(6), 2018.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, small sample size, overall technical success rate of (b)(4), cumulative rate of 30-day vascular access complications was (b)(4) and the fact that secondary endovascular repair of recurring lesions and perioperative complications after oar is extremely challenging procedure, one can infer that the getinge¿s advanta v12 balloon expandable covered stents performed as expected.The authors did not attribute patients¿ adverse effects to any particular type of bridging stent.

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: 11515598
• MDR Text Key: 240635401
• Report Number: 3011175548-2021-00328
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/24/2021
• 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