MAUDE Adverse Event Report: Atrium Medical Corporation FLIXENE SLIDER GDS; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Model Number	25138
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an implanted flixene graft tested positive for pseudomonas aeruginosa infection on (b)(6) 2026.The graft was explanted during surgical revision.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.

• Brand Name: FLIXENE SLIDER GDS
• Common Device Name: 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: 50737153
• Report Number: 3011175548-2026-000010
• Device Sequence Number: 10662112
• Product Code: DSY
• UDI-Device Identifier: 00650862251388
• UDI-Public: (01)00650862251388
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: 25138
• Device Catalogue Number: 25138
• Device Lot Number: 511939
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: unknown.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 222 LB