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); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received an article: keschenau, p.E.(2020).Changes in target vessel anatomy following fenestrated endovascular aneurysm repair: midterm results.Journal of endovascular therapy, 445-451.Purpose: to analyze the changes in target vessel (tv) anatomy after fenestrated endovascular aneurysm repair (fevar) during mid-term follow up.Method: a retrospective study that analyzed 56 patients who underwent fevar using customer-made stent-grafts between 2010 and 2016.Conclusion: no difference was found between the v12 and the beg stent-grafts regarding anatomical tv changes.Per the article adverse events included blood loss, stenosis and occlusion.

Event Description

N/a.

Manufacturer Narrative

Additional information section: d9, h6.This complaint is based on information within an article and no specific device information has been provided.As there is insufficient details of an actual device malfunction or adverse event that occurred the complaint cannot be confirmed.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.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, high target vessel patency rates, low number of complications despite significant anatomical changes of the renovisceral arteries after fevar procedure and the fact that there was no difference found between the advanta v12 and the begraft stent-grafts regarding anatomical target vessel changes during midterm follow-up after fevar, one can infer that the getinge¿s advanta v12¿ balloon expandable covered stent performed as expected.H3 other text : product not returned.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 11389298
• MDR Text Key: 233963661
• Report Number: 3011175548-2021-00240
• 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: 08/24/2022

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: 08/21/2022
• 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