ATRIUM MEDICAL CORPORATION FLIXENE GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study, leaving patients with vascular access dysfunction to fate (no intervention) or avf ligation is always simpler and easier.However, it should not be forgotten that paternity for vascular access are limited in these patients.Product not available for return.
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Event Description
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Received an article titled: kahraman, n.E.(2019).Outcomes of arteriovenous fistula reconstruction in vascular access dysfunction.Am j transl res, pp.1058-1065.Purpose: we investigated avf rescue operations, which we performed for the pathologies causing dysfunctional vascular access, and outcomes of these operations by surgeon-performed preoperative ultrasound (us) in our clinic.Method: 67 patients who were treated in our clinic due to avf dysfunction between january 2012 and january 2016 were included in the study.Per the article adverse events included bleeding and infection.
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Search Alerts/Recalls
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