Catalog Number ECH060040A |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
Thrombus (2101)
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Event Type
Injury
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Event Description
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On (b)(6) 2014, a patient was implanted with a gore® acuseal vascular graft for arteriovenous access.The dialysis center reported to gore that the graft clotted within the first several weeks post implantation date.The graft is currently open and able to be dialized.
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Event Description
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The graft is still implanted but the clots have been removed and it is difficult to dialyze the patient through the graft.
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Manufacturer Narrative
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Results: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Conclusions: the device remained implanted; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.
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Search Alerts/Recalls
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