As reported by the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, fracture.The device was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿filter-fractured-in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Procedural/handling factors, or vessel characteristics, although unknown, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.However, reports of adverse clinical sequelae from filter fractures are rare.Without images available for review the reported event could not be confirmed or further clarified.As no lot number or other product information was supplied a phr could not be completed.The little information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Should additional information become available, the file will be updated accordingly.
|
As reported by the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to fracture.
|