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

Model Number	25135
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.Due to character restrictions in block e1 event site name: (b)(6).
Event or Problem Description
It was reported that during a procedure, the surgeon was preparing the flixene graft for use in the or by cutting the tapered end at an angle.The surgeon observed that the graft did not appear to be properly sized and used a 5mm dilator to measure the cut end.The 5mm dilator slid easily in and out of the graft, indicating that the sizing was incorrect.As the smaller sizing was required, the surgeon opened a vxt graft to complete the case.There was no patient injury or harm reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional section: h6.This complaint reports that a 4-7mm x 45cm flixene graft (p/n 25135, l/n 513795) was oversized.The user stated that they cut the tapered end (4mm end) to the desired angle and observed that it then looked too large.They inserted a 5mm dilator into that end of the graft and report that it slid in and out easily.They then swapped for another graft because they needed it to be 4mm.The user provided a video of the 5mm dilator being inserted into the graft.The video confirms that the narrow end of the graft is being tested.However, it can be seen in the video that as the dilator is being inserted, the sides of the graft bulge outward.This indicates that the outer diameter of the 5mm dilator is greater than the inner diameter of the 4mm graft, which is to be expected.The reason the user was able to slide the dilator in and out of the graft easily is because the graft material is flexible, to allow it to move naturally within the body once implanted.It can be seen in the video that once the dilator is removed, the graft returned to its original size.The graft was returned for evaluation.The material was covered in dried blood and was rather stiff.A 4mm (0.158) minus pin gauge was able to be placed into the 4mm end of the graft with very slight interference.When a 5mm (0.196 ) pin gauge was attempted to be placed into the 4mm end of the graft, the pin could not pass indicating that the 5mm pin gauge was too large.Based on this evaluation combined with the results of the video where it is easily seen that the material is expanding to allow the 5mm dilator to pass, there is no evidence of an inner diameter of the graft discrepancy.A dhr review was completed for lot 513795 and top assemblies and no anomalies were identified in manufacturing.All samples passed inner diameter inspection.A recurring lot number query was conducted for the lot and there have been no other complaints associated with the production lot of finished goods.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.There is no indication that the ifu is related to this complaint.A historical review of capa and ncrs was completed, which did not identify any issues directly related to this complaint.A complaint history review was completed which found one similar complaint submitted by the same clinician.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.The complaint is confirmed but a device nonconformance is not.The returned graft was found to be the correct size and within specifications.The root cause of this complaint is user preference.

• 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: 22745717
• Report Number: 3011175548-2025-000009
• Device Sequence Number: 8972403
• Product Code: DSY
• UDI-Device Identifier: 00650862251357
• UDI-Public: (01)00650862251357(17)270930
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 25135
• Device Catalogue Number: 25135
• Device Lot Number: 513795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 90 KG