Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Hematoma (1884); Myocardial Infarction (1969)
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Event Date 06/13/2014 |
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 right brachial artery to the cephalic vein for arteriovenous access.The graft was cannulated on (b)(6) 2014.The patient presented with a peri-operative mi on the third day following implant.It was reported to gore that the patient presented with an extensive hematoma around the graft which was caused by the anticoagulation medication to treat the mi.The graft was unable to be cannulated for 10 days.On (b)(6) 2014, a temp line was inserted 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.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: perigraft hematomas.
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Search Alerts/Recalls
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