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	Ischemia (1942); Thromboembolism (2654); Limb Pain (4836)
Date of Event	05/05/2022
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 developed acute lower extremity ischemia and presented with severe lower back pain radiating into both legs.On evaluation, the lower extremities were cold and tender, with absent palpable pulses and no sensory or motor deficits.Ct angiography revealed a thrombus extending from the infrarenal aorta to the bilateral common iliac arteries.The patient underwent emergency surgical intervention, including a left axillo-femoral bypass and bilateral iliac, superficial femoral, deep femoral, and cross-bypass thrombectomies.A graft reintervention consisting of endovascular thrombectomy was successfully performed on (b)(6) 2022.Patency was restored, no amputation was required, and the adverse event subsequently resolved.
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name: (b)(6) initial reporter: (b)(6) based on the complaint investigation, a retrospective review was conducted as part of the post-market clinical follow-up (pmcf) registry for advanta vxt and flixene vascular grafts.The pmcf registry is a multicenter observational study evaluating the long-term safety and performance of grafts implanted between december 31, 2010, and december 31, 2021.During retrospective review of patient records, adverse events including thrombosis, graft occlusion, infection, restricted blood flow, and/or the need for additional surgical intervention were reported.The manufacturer performed an investigation in accordance with established complaint handling procedures.Review of the available information determined that the reported events are consistent with known complications associated with vascular graft implantation and are recognized adverse events identified in the device instructions for use (ifu aw011456).Review of complaints received through the pmcf registry demonstrated a common pattern in which reported events were associated with patient comorbidities, progression of underlying vascular disease, and anticipated procedural complications.No physical product, photographs, or other objective evidence were provided for evaluation, and there was no information indicating a device malfunction, manufacturing deficiency, or design-related issue.A device history record review was not required because no device malfunction or product nonconformance was alleged or identified.Complaint trending and risk management records were reviewed.The reported hazard-harm combinations are documented and adequately addressed within the dfmeca for eptfe vascular grafts.Although an increase in thrombosis and occlusion complaints was observed during pmcf data collection, the increase was attributed to the influx of retrospective cases identified through the registry rather than a change in device performance.No new or increased risk was identified, and no capa, field action, or other corrective action was initiated as a result of this investigation.Based on the available information, the manufacturer was unable to confirm a device-related cause for the reported event(s).The investigation concluded that the event was most likely associated with patient factors, disease progression, and/or known procedural risks.The device was determined to have operated within specification, and no evidence was identified to suggest that the advanta vxt or flixene vascular graft contributed to the event through a product deficiency.The investigation is complete and no further action is warranted at this time.

• 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: 50816245
• Report Number: 3011175548-2026-000011
• Device Sequence Number: 10647976
• Product Code: DSY
• UDI-Device Identifier: 00650862222227
• UDI-Public: (01)00650862222227(17)210828
• 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: 2019
• 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): 09/18/2026

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: 08/28/2021
• Device Model Number: 22222
• Device Catalogue Number: 22222
• Device Lot Number: 435408
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2018
• 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 Age: 72 YR
• Patient Sex: Male