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

Model Number	22222
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Stenosis (2263); Obstruction/Occlusion (2422)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to character restrictions in block e1\ initial reporter name: (b)(6)\ event site name: (b)(6) \ \ a supplemental report will be submitted upon completion of our investigation.
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 developed stenosis of the distal graft anastomosis, resulting in graft occlusion and requiring a graft reintervention.On (b)(6) 2022, the patient underwent a successful endovascular intervention with balloon angioplasty and stent placement, restoring graft patency.No procedural complications were reported.

• 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: 50519242
• Report Number: 3011175548-2026-000010
• Device Sequence Number: 15833142
• Product Code: DSY
• UDI-Device Identifier: 00650862222227
• UDI-Public: (01)00650862222227(17)231202
• 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
• 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: 12/02/2023
• Device Model Number: 22222
• Device Catalogue Number: 22222
• Device Lot Number: 465236
• 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: 08/11/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2020
• 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