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
Death (1802); Unspecified Infection (1930); Seroma (2069)
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Event Type
Death
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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, the haemodialysis reliable outflow graft provides acceptable 12-month secondary patency rates and acceptable complication rates in a uk and ireland multi-centre series of complex access patients.Product not available for return.
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Event Description
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Received an article titled: hunter, j.E.(2019).The united kingdom and ireland experience of the haemodialysis reliable outflow graft for vascular access.The journal of vascular access, pp.12-18.Purpose: to describe the uk and ireland experience of the haemodialysis reliable outflow graft in complex vascular access.Method: data from any patient undergoing haemodialysis reliable outflow graft were collected from eight uk and one irish centre.Per the article deaths occurred within the study period.
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Search Alerts/Recalls
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