The lot number for all the three reported malfunctions was not provided, therefore a lot history reviews were not performed.
The devices were not returned for evaluation as well as medical records were not provided.
Therefore, the investigation for the three reported malfunctions are inconclusive for filter tilt, filter migration, occlusion of the inferior vena cava (ivc) filter, filter detachment and perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter.
Based on the available information, the definitive root cause is unknown.
The devices are labeled for single use.
|
This report summarizes three malfunctions.
A review of the reported information indicates that model unk denali vena cava filter allegedly migrated, perforated, occluded, tilted and detached.
These reports were received from various sources.
Three malfunctions were involved with no reported patient injury.
Of the three reported malfunctions, two were female and one was male.
Age and weight for all the three malfunctions were not provided.
|