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	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name: (b)(6).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.There was no adverse event reported.
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 3 pieces of graft.One is the gds end, one is labeled as "one end of the graft" (presumably the distal end), and another longer segment.The majority of this 50 cm long graft is not included in the picture.The pieces of graft in the provided picture were returned for evaluation.Tactile examination determined that both the gds end and the other labeled end are both graduated.The wall thicknesses of the 3 segments that the shorted end pieces have visibly thinner walls.A large portion of the graft is missing, but the segments that were returned confirm that both ends of the graft were graduated.A dhr review was completed for lot: 511553 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: 511553.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 returned pieces of graft confirm that both ends of the graft had graduated walls.The most likely cause of this complaint is user preference.
Event or Problem Description
Additionally it was reported that the physician proceeded with the procedure by using the middle portion of the graft.There was no patient harm reported.
Additional Manufacturer Narrative
Additional section: a2, a4, a5, a6, a7, b5, d6a.

• 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: 23580161
• Report Number: 3011175548-2025-000012
• Device Sequence Number: 18536353
• Product Code: DSY
• UDI-Device Identifier: 00650862250589
• UDI-Public: (01)00650862250589(17)270823
• 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: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2026

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: 511553
• 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: 11/28/2025; 01/09/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 55 KG