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

Model Number	25137
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that flixene graft had humidity levels exceeded 80% for more than 24 hours and reached up to 100%.During inspection, bubbling was observed on the product labeling, and all products felt cold as if like they were defrosted.There was no patient involved or adverse event reported.
Additional Manufacturer Narrative
Related complaint: (b)(4).Upon completion of the investigation into this event a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: e1 (event site email, initial reporter).
Event or Problem Description
N/a.

• 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: 24632652
• Report Number: 3011175548-2026-000003
• Device Sequence Number: 18356040
• Product Code: DSY
• UDI-Device Identifier: 00650862251371
• UDI-Public: (01)00650862251371(17)280604
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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: 25137
• Device Catalogue Number: 25137
• Device Lot Number: 521069
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 05/08/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/14/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown