Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Injury (2348)
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Event Date 06/03/2015 |
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 remained implanted; 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 axillary vein for arteriovenous access.The graft was cannulated on (b)(6) 2014.It was reported to gore that on (b)(6) 2015, the patient presented arterial steal and the graft was ligated.An arteriovenous fistula was created for dialysis 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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Physician stated the event was not related to the graft itself, but was related to the patient's condition.
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Search Alerts/Recalls
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