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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Ischemia (1942)

Event Type  Injury  

Event Description

Article received: renard, r.E.(2021).A hybrid clampless technique for aortic anastomoses.Journal of vascular surgery cases and innovative techniques, 137-141.Objective: we here describe a simple and reproducible hybrid technique that allows performing an aortic anastomosis without clamping in these situations.Method: after a limited exposure of the anterior aortic wall in a healthy segment, a prosthetic graft is sutured without any arteriotomy or clamping (adventitial suture), mimicking the final aspect of an end-to-side anastomosis.The graft and the anastomosis site are punctured using a long needle, allowing a guidewire to be positioned in the aorta under fluoroscopic guidance.Protected covered stenting of the anastomosis site opens the anastomosis without aortic clamping.After tunneling the graft to the target artery, the distal anastomosis is performed in a usual fashion.Conclusions: this hybrid clampless technique for aortic anastomosis represents a useful alternative for challenging lesions unsuitable for a simple open or endovascular treatment.Per the article adverse events included acute limb ischemia and postoperative infection of graft.

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.Not available for return.

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 perfection trial was a prospective, multi-center study designed to assess the clinical efficacy of the novel fusion vascular graft.Patency rates equaled or exceed those reported with other nonbioactive vascular grafts and compare favorably with data from many studies of heparin-coated prostheses.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 a small sample size, no early mortality, no embolic events, no ischemic symptoms, overall low rate of complications, which were not related to performance of getinge devices and the fact that hybrid aortic clampless anastomosis is feasible and safe alternative in case of lesions unsuitable to an endovascular treatment, one can infer that the getinge¿s fusion hybrid vascular graft and 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: 12800077
• MDR Text Key: 284877146
• Report Number: 3011175548-2021-01119
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• 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: 11/11/2021
• 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