MAUDE Adverse Event Report: Atrium Medical Corporation ADVANTA SLIDER GDS; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Model Number	22221
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As part of post-market clinical follow-up (pmcf) registry for vxt and flixene grafts the following adverse event information was provided regarding a vxt graft.The patient implanted with an advanta graft developed a bypass graft infection, characterized by wound dehiscence and purulent discharge along the prosthesis.The patient underwent wound debridement and tissue sampling.Microbiological testing identified klebsiella pneumoniae and enterococcus faecium.The adverse event outcome was reported as resolved with sequelae.Surgical intervention was performed, and graft reintervention was required.On (b)(6) 2021, an explant procedure was performed due to the graft infection.During explantation, the prosthesis fractured, resulting in a small fragment remaining in the thigh.Surgical intervention was successful.
Additional Manufacturer Narrative
Due to character restrictions in block e1.Initial reporter name: (b)(6).Event site name: (b)(6).

• Brand Name: ADVANTA 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: 50518994
• Report Number: 3011175548-2026-000009
• Device Sequence Number: 21159504
• Product Code: DSY
• UDI-Device Identifier: 00650862222210
• UDI-Public: (01)00650862222210(17)231007
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K992960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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 Expiration Date: 10/07/2023
• Device Model Number: 22221
• Device Catalogue Number: 22221
• Device Lot Number: 464875
• 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: 08/10/2026
• Initial Report FDA Received Date: 08/31/2026
• 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: Unknown
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male