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 Obstruction/Occlusion (2422); Valvular Stenosis (2697); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received an article: overeem, s.E.(2020).Validation of a novel methodology to evaluate changes in the flare geometry of renovisceral bridging stent-grafts after fenestrated endovascular aneurysm repair.Journal of endovascular therapy, 436-444.Purpose: to validate a novel method to evaluate changes in the geometry of renovisceral bridging stent-grafts in patients undergoing fenestrated endovascular aneurysm repair.Method: retrospective analysis was conducted of serial computed tomography angiograms of 10 fevar patients with at least 2 years of cta follow-up conclusion: precise assessment of the geometry of visceral bsgs in fevar is feasible with the presented method.Per the article adverse events included endoleaks, occlusion, stenosis and thrombus.

Event Description

N/a.

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.Attempts to obtain the device lot information was conducted but unsuccessful.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 with small sample size, 100% technical success rate, among two patients with ra restenosis after 30 days, one underwent successful endovascular revision and another one had no impairment of renal function, all bcgs with type iiic endoleak or occlusion, the complication was preceded by the obvious change in the bcg geometry and the fact that bcgs included in the study were not the same or equally distributed, 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: 11478493
• MDR Text Key: 239685101
• Report Number: 3011175548-2021-00306
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2021
• 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: 09/05/2022
• 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