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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Received an article: silverberg, d.E.(2020).Chimney endovascular repair of primary mycotic aneurysms involving the paravisceral aorta.Annals of vascular surgery, 59-66.Purpose: the purpose of this study is to report an experience with chimney evar (chevar) in patients with mycotic aortic aneurysms.Method: a retrospective review of all patients treated with evar at our institution between 2009 and 2019.Conclusion: chevar is a feasible and safe treatment modality for maas involving the visceral segment.Per the article adverse events included renal failure and sepsis.

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 design of the study, excellent technical success rate, no stent occlusion of the pgs occurred, no required reintervention due to endoleaks and the fact that no patient required explanation of the stent grafts or conversion to an open repair, one can infer that the getinge¿s advanta v12 balloon expandable covered bridging stents performed as expected.Authors emphasized that intentional occlusion of the selected visceral arteries was required to minimize the risk of gutter endoleaks in this urgent setting.H3 other text: product not available.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED
• 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: 11389396
• MDR Text Key: 233963938
• Report Number: 3011175548-2021-00248
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 08/10/2022
• 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