Catalog Number 352506070E |
Device Problem
Difficult to Fold, Unfold or Collapse (1254)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation and no images or videos have been provided of the filter in-vivo, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.
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Event Description
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An option elite ivc filter was deployed from the ij using the over the wire technique with an amplatz wire from boston scientific.After the filter was deployed, the legs on the filter did not open.This wasn't fully realized until after the delivery system was completely removed.The physician gained access again from the ij, inserted a wire and upon contact with the filter the legs untangled and opened as they should normally.The physician was satisfied at that point and left the filter in place.
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Search Alerts/Recalls
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