Catalog Number 466FXXXX |
Device Problem
Expulsion (2933)
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Patient Problem
Thrombosis (2100)
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Event Type
Injury
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Manufacturer Narrative
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The product remains implanted and is thus not available for analysis.As indicated in a legal brief, plaintiff underwent placement of optease vena cava filter on or about (b)(6) 2009.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc filter.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication.Factors that may have influenced the event include patient, pharmacological and lesion.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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Event Description
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As indicated in a legal brief, plaintiff underwent placement of optease vena cava filter on or about (b)(6) 2009.The filter subsequently malfunctioned and caused injury and damages to plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc filter.As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
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Search Alerts/Recalls
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