The age and gender were completed with the provided mean age and mean gender of the article.Date of event was completed with the date when the article was accepted as individual date of event was not stated in article.Results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass¿, published by gabriele piffaretti et al, within the journal of vascular surgery.
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Within the article ¿results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass¿, published by gabriele piffaretti et al, within the journal of vascular surgery, the article indicates the following: the aim of the study was to retrospectively analyze early and follow-up results of above-the-knee femoropopliteal bypasses (akb) performed with a bioactive heparin-bonded expanded polytetrafluoroethylene (hb-eptfe) graft (gore propaten) in patients with peripheral arterial obstructive disease in a multicentric retrospective registry.During a 14-year period ending in (b)(6) 2016, an hb-eptfe graft was used in (b)(4) interventions performed for peripheral arterial obstructive disease.A post hoc analysis of the database was performed to identify (b)(4) (25.9%) patients who underwent akb.Early (intraoperative and <30 days) results were analyzed in terms of death, thrombosis, amputations, reinterventions, and the occurrence of major local and systemic complications.Follow-up results were analyzed by life-table analysis in terms of primary and secondary graft patency, assisted primary patency, limb preservation, and amputation-free survival.During follow-up, two patients suffered from fatal sepsis, whereas pulmonary embolism, stroke, and car accident were the causes of death in one patient each.
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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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Corrected data: h1 - type of reportable event, h6 - device code 1, h6 - results code 1, h6 - conclusions code 1.Additional manufacturer narrative: input from the gore product specialist and the gore office of medical affairs determined this event is not device related.Therefore this event is not reportable to the fda and is retracted.
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