As reported through the legal department via a legal brief, the patient had an optease inferior vena cava (ivc) filter implanted.The following additional information was received per the patient¿s implant records: the filter was implanted below the level of the renal veins due multiple trauma with contraindication to anticoagulation for dvt prophylaxis.Additional information provided reported the filter was unable to be retrieved due to being embedded into the wall of the ivc, struts of the filter were 1-2mm outside the lumen wall, and some bends in the struts in the upper right portion of the filter.As a further proximate result, the patient has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.According to the information received in the patient profile form (ppf), an unsuccessful percutaneous removal attempt was made approximately ten months post implantation.The patient also reports suffering from anxiety.
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Complaint conclusion: as reported, the patient had an optease inferior vena cava (ivc) filter implanted below the level of the renal veins due multiple traumas and a contraindication to anticoagulation for deep vein thrombus prophylaxis.Attempts to retrieve the filter approximately ten months after its¿ implantation were unsuccessful due to its¿ being embedded into the wall of the ivc.The struts of the filter were 1-2mm outside the lumen wall with some bends in the struts in the upper right portion of the filter.As a further proximate result, the patient has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.The patient also reports suffering from anxiety.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The optease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.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.Without procedural films for review, the reported filter strut kink/bend could not be confirmed and the exact cause could not be determined.The timing and mechanism of this issue has not been reported at this time.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 kinking of a particular filter strut.Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.The reported details indicate that retrieval was attempted approximately ten months after implantation.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's instructions for use may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as twelve days.The brief also reported perforation of the ivc.However, a clinical conclusion could not be determined as to the cause of the event.It is unknown if the kinked/bent struts contributed to the reported perforation.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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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