Device Problems
Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
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Patient Problems
Death (1802); Myocardial Infarction (1969)
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Event Date 06/30/2014 |
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 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 left superficial femoral artery to the femoral vein for arteriovenous access.It was stated that during the implant procedure the patient experienced a myocardial infarction.The graft was cannulated on (b)(6) 2014.It was reported to gore that on (b)(6) 2014, the graft lost primary and functional patency and the patient expired due to a myocardial infarction.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.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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Search Alerts/Recalls
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