ADVANTA SLIDER GDS
Received Jul 31, 2026 · Event occurred Jul 8, 2022
Report 3011175548-2026-000008 · MDR key 50101705
Device
Generic name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Manufacturer
Atrium Medical CorporationModel number
22187Catalog number
22187
Lot number
452140
Product problems
- Obstruction of Flow
Patient
Not reported
- Thrombosis/Thrombus
Narrative
Description of Event or Problem
As part of the Advanta VXT and Flixene PMCF Registry, a report was received related to a VXT graft. It was reported that the patient implanted with Advanta VXT graft had developed exertional pain in the left lower limb and was admitted to the hospital. On examination, the bypass graft was thrombosed. A CT scan demonstrated occlusion of the femoropopliteal bypass graft. This event represented loss of primary graft patency. A thrombectomy intervention was performed. The adverse event resolved.
Additional Manufacturer Narrative
Due to character restrictions in block E1.Event Site Name: (b)(6).A supplemental report will be submitted upon completion of our investigation.