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

Model Number	25053
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1: event site name: (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that flixene graft is clotted after implanting it.There was no adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional section: e3, h6.The customer reported that a flixene graft clotted after 11 days.The device in question has not been explanted and no images of the graft have been provided and therefore the complaint cannot be confirmed.Several good faith efforts (gfe) inquiries were made regarding the reported event to the complainant without any answers provided except for the response that the issue was resolved and was not related to the graft, that there was an increase in infection markers related to chest infection and was not related to the graft implantation.Based on the additional information the clotting of the graft as described is likely attributed to the patient conditions and operational context of the procedure.A device history record review and a recurring lot number query was unable to be conducted as the lot number of the device was not provided.The hazardous situation and harm are properly covered within the risk-based documents and the instructions for use are adequate to ensure the proper use of the graft as well as the warnings and precautions are appropriate.A historical review of capa, ncrs and complaint history were completed, which did not identify any issues directly related to this complaint, as the reported issue was resolved and associated with patient conditions and not related to the graft implantation.Based on the information provided the root cause is related to the operational context likely attributed to the patient conditions.The complainant had responded that the issue was resolved and was not associated to the graft, that there was an increase in infection markers related to chest infection and was not related to the graft implantation.

• Brand Name: FLIXENE
• 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: 23987547
• Report Number: 3011175548-2026-000000
• Device Sequence Number: 4630261
• Product Code: DSY
• UDI-Device Identifier: 00650862250534
• UDI-Public: (01)00650862250534
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25053
• Device Catalogue Number: 25053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Sex: Unknown