Within the article ¿prevalence and risk factors for heparin-bonded expanded polytetrafluoroethylene vascular graft infection after infrainguinal femoropopliteal bypasses¿, published by gabriele piffaretti et al, within the journal of vascular surgery, the article indicates the following: the multicenter study retrospectively evaluated prosthetic vascular graft infection (pvgi) that developed after infrainguinal revascularization (femoropopliteal bypasses) performed with a heparin-bonded expanded polytetrafluoroethylene graft (gore propaten graft) that was used in 1400 interventions between 2002 and 2016.Critical limb ischemia (cli) was the main indication for bypass (65%).A prosthetic graft with infection was defined as direct involvement of the graft with positive bacterial cultures of graft or perigraft material, intraoperative gross purulence or failure of graft incorporation, or exposed graft in an infected wound.A total of 33 heparin-bonded expanded polytetrafluoroethylene grafts (2.3%) became infected; the median time to occurrence was 5 months.The infected graft was explanted in all patients.Early graft thrombosis (<30 days) occurred in 6% of patients.
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Additional manufacturer narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #unknown.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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