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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to character restrictions in block e1 initial reporter- (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that multiple occlusion events occurred within a few days after flixene graft implantation.It was identified that the 4mm tapered segment had become occluded, and ultrasound imaging showed that the outer wall of the flixene graft appeared wavy.
Additional Manufacturer Narrative
Additional information: h6.The customer reported that there were occlusion events that occurred after flixene graft implantation.It was identified that the 4mm tapered segment had become occluded, and ultrasound imaging showed that the outer wall of the flixene graft appeared wavy.Based on the details of the complaint and images provided it is impossible to determine the cause of the complaint.The images provided suggest that there has been a separation in the wall of the graft possibly from using the same site for dialysis or from using the wrong size gauge needle for dialysis.Within one of the images provided there is a large space at the distal end that is likely 7mm based on the flixene tapered graft being a tapered graft 7mm to 4mm.This itself is considered normal, however if there was a hole in the graft at this location (4mm end) blood would quickly fill into this space creating a hematoma.The construction of the graft is a eptfe tube with the inner base material being thicker than the rest of the outer eptfe wall.In this regard there is no inner wall material that could separate causing blockage.After several attempts to obtain additional information from the physician was unsuccessful it is difficult to determine the root cause of the complaint.The complaint has been confirmed based on the images provided, however we cannot confirm that the graft design or manufacture is the cause of the complaint.There are too many unknown factors associated with this complaint.A device history record review and recurring lot number review was unable to be conducted as the lot number of the device was not provided.There is no evidence identified to suggest that this complaint is related to design, manufacturing, materials.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 complaints were conducted.There were no ncr¿s related to this reported event description.There were two corrective action requests and one capa associated with the separation of layers on the outside of the graft.This was deemed user error based on undersized tunneler tips that were used in the procedure.The complaint history review did identify a few related complaints which were deemed to be associated with patient comorbidities.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.Based on the limited details provided and the lack of information from the complainant the root cause is impossible to define.The images provided suggest that there has been a separation in the wall of the graft possibly from using the same site for dialysis or from using the wrong size gauge needle for dialysis.
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: 24362721
• Report Number: 3011175548-2026-000001
• Device Sequence Number: 10200653
• Product Code: DSY
• UDI-Device Identifier: 00650862251388
• UDI-Public: (01)00650862251388
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25138
• Device Catalogue Number: 25138
• 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: 01/24/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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: BARD TUNNELER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male