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

Device Problem Use of Device Problem (1670)

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: gibello, l.E.(2020).Current results of balloon expandable visceral stent-grafts in fenestrated endografting.Journal of cardiovascular surgery, 37-46.Purpose: the purpose of this systematic review is to analyze the results of currently used balloon expandable bridging stent-grafts and to evaluate the newest developments for fenestrated endovascular aortic repair (fevar) in juxtarenal endovascular repair.Method: data was retrieved from retrospective analyses, case series and case reports conducted from 2000 to september 2019.A total of 11 studies khoury et al speaks specifically v12/icast conclusion: the better understanding of the system fevar-native aorta, the strict collaboration and exchange of expertise between physicians and engineers and the consequent improvement of graft flexibility and resistance could really increase the performances of the bridging stent-graft and reduce reinterventions and complications in fevar.Per the article adverse events included: occlusion, branch instability.

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.Conclusion: the instructions for use clearly states that potential adverse effects of advanta v12 balloon-expandable stent include, but may be not limited to: restenosis of stented lesion, short-term hemodynamic deterioration, systemic embolization or thromboembolic episodes, and vascular thrombosis.Considering the design of the study as retrospective systematic review of scientific publications with some data adjudicated by investigators, high technical success rate of icast/advanta v12 stents, high primary patency rate, excellent freedom from branch instability and low mortality rate, one can infer that getinge¿s icast/advanta v12 balloon expandable covered stents performed as expected.The authors do not attribute development of complications to any particular stent type.

• Brand Name: ADVANTA V12 COVERED STEN
• 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: 11382564
• MDR Text Key: 233725435
• Report Number: 3011175548-2021-00218
• 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: 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

• 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: 02/16/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 08/21/2022
• Supplement Dates FDA Received: 08/24/2022
• 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