Catalog Number 352506070E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Calcium Deposits/Calcification (1758); Perforation (2001)
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Event Date 06/16/2017 |
Event Type
Injury
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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 re-evaluated as needed.
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Event Description
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According to the notice received by way of a civil action complaint filed on (b)(6) 2019, the patient was prescribed and implanted with an option elite retrievable ivc filter on or about (b)(6) 2017 by (b)(6).The complaint alleges tilt and perforation.The complaint specifically alleges ¿mild aortic calcification.¿ argon¿s attorneys are attempting to gather additional information.
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Search Alerts/Recalls
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