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

Model Number	22185
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Necrosis (1971); Obstruction/Occlusion (2422)
Date of Event	11/15/2020
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 underwent a ct scan that revealed occlusion of the lower limb arteries.Treatment was initiated with a femoroperoneal bypass and aponeurotomies however the patient's condition deteriorated, resulting in muscle compartment necrosis.On (b)(6) 2020, a surgical reintervention was performed, which included target limb amputation at or above the ankle.No procedural complications were reported, and the reintervention was considered successful.The adverse event was reported as resolved with sequelae.
Additional Manufacturer Narrative
Due to character restrictions in block e1.Initial reporter: (b)(6).Event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.

• 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: 50519457
• Report Number: 3011175548-2026-000010
• Device Sequence Number: 13088741
• Product Code: DSY
• UDI-Device Identifier: 00650862221855
• UDI-Public: (01)00650862221855(17)230731
• 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: 2020
• 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: 07/31/2023
• Device Model Number: 22185
• Device Catalogue Number: 22185
• Device Lot Number: 462500
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2020
• 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: Unknwon
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female