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

Model Number	25058
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 the physician did not perceive the graduated wall feature on the flixene graft, as the wall thickness did not appear reduced toward the end during handling.Further to continue the procedure, the physician trimmed one end of the graft and proceeded with the procedure using the middle portion.There was no harm on the patient.
Additional Manufacturer Narrative
Additional field: d6a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: h6.The customer reported that the graduated wall feature on the flixene (25058) graft, as the wall thickness did not appear reduced toward the end during handling.Flixene grafts with graduated walls on either end receive an additional wrap on the ends of the grafts during manufacturing.One possible explanation for this complaint is if that step was missed during manufacturing.Another is if the oven temperatures were not set or maintained correctly and the wrap did not properly set.Either of these errors should have been noted in the dhr, but the dhr for the top assembly shows the procedure was completed and the oven temperatures were correct.Another possibility is that the graduated wall is present, but the user simply could not tell the difference.This could be the case since the graft was being manipulated and placed in the patient, which can make it difficult to tell a subtle difference in the wall thickness.It is also possible that the graduated ends of the graft were trimmed off when the graft was being cut to the length needed for the procedure.A picture was provided by the user which shows two pieces of a graft, with the majority of the graft not pictured.The picture shows the gds end of the graft and another segment that is labeled as "the other end." the two pieces of graft from the provided picture were returned for evaluation.Most of the graft was not returned.The tactile examination of the gds end confirmed that end of the graft is graduated, as it feels less stiff than the center of the graft.The smaller segment of graft was also examined and it felt stiffer, like a non-graduated segment.The wall thickness of the two segments was examined and it was confirmed that the smaller segment is not graduated.However, that segment of graft also appears to have been roughly cut, which is not consistent with how grafts are trimmed during manufacturing.The evidence indicates that this is most likely not the end of the graft and is a piece trimmed from further in.Neither the complaint nor a device nonconformance can be confirmed.The majority of the graft was not returned for evaluation.The pieces that were returned confirm that the gds end is graduated and the other piece of graft does not seem to be the distal end.There are several possible causes of this complaint.It is possible that the user trimmed the ends of the graft too far or they were simply unable to perceive the graduated wall, as they stated in the report.The information available indicates the graft meets specification and this is most likely a user preference issue.A dhr review was completed for lot 518643 and the top assemblies and no anomalies were identified in manufacturing.There is no evidence to suggest that manufacturing, equipment, or design are related to the complaint root cause.The ifu provides adequate instructions for the use of this device and cautions the user not to use the device if it is defective or damaged.A complaint history review was completed which found no similar complaints other than complaint (b)(4) which was also found to meet specification.No related crs/capas were identified.No related ncrs were identified.A recurring lot number review identified no other complaints involving lot 518643.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.Neither the complaint nor a device nonconformance can be confirmed.The majority of the graft was not returned for evaluation.The pieces that were returned confirm that the gds end is graduated and the other piece of graft does not seem to be the distal end.There are several possible causes of this complaint.It is possible that the user trimmed the ends of the graft too far or they were simply unable to perceive the graduated wall, as they stated in the report.The information available indicates the graft meets specification and this is most likely a user preference issue.

• 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: 23579682
• Report Number: 3011175548-2025-000012
• Device Sequence Number: 13156262
• Product Code: DSY
• UDI-Device Identifier: 00650862250589
• UDI-Public: (01)00650862250589(17)280327
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/16/2026

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: 25058
• Device Catalogue Number: 25058
• Device Lot Number: 518643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 01/16/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/09/2026; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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