MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Seroma (2069); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: chang, j.E.(2021).Single asian center experience using the flixene early cannulation graft for hemodialysis access creation.Annals of vascular surgery, 1-7.Purpose: the aim of this study was to review the efficacy of the flixene hemodialysis arterio-venous graft (avg) in a multiethnic asian cohort of patients with end-stage renal failure (esrf).Method: patients with esrf who underwent flixene graft implantation over a two-year period were included to allow at least one-year follow-up.Conclusion: flixene early cannulation graft is comparable with other avgs in terms of patency and infection rates.Per the article adverse events included infection, steal syndrome, seroma, dehiscence, pseudoaneurysm, bleeding and ulceration.

Event Description

N/a.

Manufacturer Narrative

Article reviewed: chang et al.2021.Single asian center experience using the flixene¿ early cannulation graft for hemodialysis access creation.Ann vasc surg; 73:171-177.The subject article is a single-center retrospective review of 158 prospectively collected patients who underwent f/bevar procedures for juxtarenal abdominal aortic aneurysms (jaaas), pararenal abdominal aortic aneurysms (paaas), and thoracoabdominal aortic aneurysms (taaas) between 2012 and 2017.This complaint is based on information found within a article/literature review.There was no product that was available for evaluation, therefore a device evaluation could not be conducted and the complaint cannot be confirmed.The author of the article did not report any major adverse patient effects as result of this event.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.The hazardous situation/harm is addressed in the risk file and is operating within its risk profile.There was no evidence within the article that the device was the cause of the reported event.The complaint history review did not identify an adverse trend, therefore no escalation to capa process is required.Conclusion: the flixene¿ vascular graft is a composite trilaminate structure graft that offers exceptional strength and durability allowing early needling.Early studies have reported satisfactory results in comparison with conventional grafts, which were usually cannulated after two to three weeks post-implantation.The flixene¿ graft could be needled within 72 hours without increased complications, which allows the creation of an avg under an emergency setting to avoid the placement of a central venous catheter (cvc).Considering that all patients were already on renal replacement therapy, 68.8% had an existing avf or avg, 20% were dialyzing via a permanent catheter, 10.4% were switched from peritoneal dialysis, 22.4% and 57.1% achieved cannulation within 1 and 2 weeks, respectively.6- and 12- month primary patencies were 33.5% and 19.6%, primary-assisted patency rates were 46.6% and 29.6% and secondary patency rate were 77.6% and 63.9%, respectively, one can infer that the getinge¿s flixene¿ early cannulation graft performed as expected.H3 other text : not available for return.

• Brand Name: FLIXENE VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: 11558947
• MDR Text Key: 241927351
• Report Number: 3011175548-2021-00363
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/28/2022

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: 03/18/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 10/29/2022
• 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