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

Model Number	25141
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information regarding requirement for the surgical intervention was received on 26 feb 2026.Due to character limitations in field e1: initial reporter: dr.(b)(6).Event site name: (b)(6).Upon completion of the investigation into this event a follow-up report will be submitted.
Event or Problem Description
It was reported that flixene graft was observed to be clotted in the large portion of the graft 17 days after implantation.The graft remains implanted and the surgeon was able to clear the clot.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information: d6a, e1(event site email), h6 customer reported that a graft thrombosis and re occlusion occurred after implantation of a flixene eptfe vascular graft (model 25141, lot 524685).The device was implanted as an arteriovenous (av) access graft.Approximately 17 days post implant, the graft was observed to be occluded due to clot formation; the graft had not been cannulated, and no patient injury was reported.The clot was surgically cleared, and the graft remained implanted.A subsequent follow up visit identified re occlusion of the graft, confirmed by clinical examination and ultrasound.Additional intervention in the form of thrombectomy was required.The patient is a 90 year old female with declining renal function and a medical history significant for diabetes, hypertension, and hyperlipidemia.The patient had not initiated dialysis at the time of the events.Postoperative anticoagulation therapy was limited to 81 mg aspirin, with no additional antiplatelet or anticoagulant therapy prescribed due to concerns related to fall risk.Intraoperative heparin was administered during both the initial implantation and subsequent thrombectomy procedures.Getinge medical affairs contacted the reporting physician to obtain additional clinical information.The physician reported that implantation was performed without complication, with appropriate antegrade bleeding and no observed inflow or outflow abnormalities.The reporting physician stated that no device related issues were identified during implantation and did not attribute the thrombotic events to the flixene graft, noting that thrombosis of unknown etiology can occur in vascular access procedures.The physician indicated the patient may have an underlying clotting disorder, which is planned for further evaluation.The device was not returned, and no images were provided; therefore, confirmatory device testing could not be performed, and the complaint could not be confirmed.Due to the inability to reproduce the event and the presence of significant patient comorbidities, a contemporaneous sample was not requested.A review of the device history record, including finished goods and top assembly records, identified no manufacturing nonconformances.All reviewed records met applicable quality and performance requirements.A review of product specifications and engineering change history did not identify any design changes relevant to the reported event.Trend analysis covering a 15 month period identified a low number of similar complaints.While a statistical excursion was identified, the actual occurrence level did not exceed the anticipated occurrence level, and escalation was performed in accordance with the applicable complaint trending procedure.Reviews of capa, ncr, and scar systems identified no related issues.Based on the available information, the root cause was determined to be user ¿ anticipated procedural complication, as thrombosis is a known adverse event associated with vascular grafts and is adequately addressed in the product risk management documentation and instructions for use.The event is most likely attributable to patient specific factors, including comorbidities and lack of postoperative anticoagulation, rather than device design, manufacturing, or material issues.
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: 24544701
• Report Number: 3011175548-2026-000002
• Device Sequence Number: 15797200
• Product Code: DSY
• UDI-Device Identifier: 00650862251418
• UDI-Public: (01)00650862251418(17)281106
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 25141
• Device Catalogue Number: 25141
• Device Lot Number: 524685
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female