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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION FLIXENE VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Sepsis (2067); Heart Failure/Congestive Heart Failure (4446); Liver Failure (4492)
Event Type  Death  
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 deaths occurred within the study period.
 
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 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: product not returned.
 
Event Description
N/a.
 
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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 Key11558944
MDR Text Key241924256
Report Number3011175548-2021-00364
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
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 09/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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 Received03/23/2021
Supplement Dates Manufacturer Received09/05/2022
Supplement Dates FDA Received09/08/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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