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

Device Problem Leak/Splash (1354)

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

Article: bosiers, m.E.(2020).Longer bridging stent-grafts in iliac branch endografting does not worsen outcome and expands its applicability, even in concomitant diseased hypogastric arteries.Journal of cardiovascular surgery, 191-5.Purpose: the aim of this study was to analyse the impact of longer bsg compared to the widely used 38mm stent-grafts in terms of reintervention rate and primary patency.Method: a retrospective analysis of collected database of all patients who underwent an endovascular aneurysm repair using an ibd between 2005 and 2015.Conclusion: the use of longer stent-grafts seems not to affect the performance of bsg even in the long run.Per the article adverse events included occlusion, endoleaks and restenosis.

Manufacturer Narrative

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: considering the retrospective single-center design of the study with some intentional heterogeneity between both groups, high technical success rate, high freedom of bsg related event or reintervention at 60 months at both groups and the fact that comparison between the two groups shows no significant difference, one can infer that getinge¿s advanta v12tm balloon expandable covered stents performed as expected.The authors do not attribute development of complications to any particular stent type.

Event Description

N/a.

• 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: 11389315
• MDR Text Key: 233963088
• Report Number: 3011175548-2021-00234
• 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: 08/12/2022

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: 08/09/2022
• 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