Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Sepsis (2067)
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Event Date 10/28/2014 |
Event Type
Injury
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Manufacturer Narrative
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No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned; consequently, a direct product analysis was not possible.
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Event Description
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On (b)(6) 2014, a patient was implanted with a gore acuseal vascular graft in the right brachial artery to the basilic vein for arteriovenous access.The graft was cannulated on (b)(6) 2014.It was reported to gore that on (b)(6) 2014, the patient presented with sepsis and the graft was explanted.A tunneled central venous catheter was implanted for arteriovenous access.This is part of a data collection study from dr.(b)(6) using the gore acuseal vascular graft for arteriovenous access.
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Manufacturer Narrative
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Corrected data: infection was initially reported for this event.Although infection did occur, the infection occurred post-arteriovenous cannulation, and therefore would not constitute a reportable event.Loss of patency within 30 days was reported as well in this event and has been included in this follow-up report.Physician stated the event was not related to the graft itself, but was related to the patient's condition.The instructions for use for gore® acuseal vascular graft state that complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis.
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Event Description
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On (b)(6) 2014, a patient was implanted with a gore® acuseal vascular graft in the right brachial artery to the basilic vein for arteriovenous access.The graft was cannulated on (b)(6) 2014.It was reported to gore that on (b)(6) 2014, the graft lost functional patency and the patient presented with sepsis.The graft was explanted.A tunneled central venous cathether was implanted for arteriovenous access.This is part of a data collection study from dr.(b)(6) using the gore® acuseal vascular graft for arteriovenous access.
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Search Alerts/Recalls
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