As reported by the legal brief, the patient underwent placement of a trapease permanent vena cava filter.The following additional information received per the patient profile from (ppf) indicates that the device was unable to be retrieved although there have been no documented attempts made to retrieve the filter.The patient also reports to have coughed up blood, shortness of breath and severe anxiety.According to the medical records, the patient had a history of esophagectomy with complicated post-operative course, pulmonary embolism (pe) and gastrointestinal (gi) bleeding due to anticoagulation.The filter was therefore placed for pe prophylaxis.The filter was deployed in the infrarenal inferior vena cava (ivc) during the index procedure and the patient tolerated the procedure well with no reported complications.
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After further review of additional information received the sections have been updated accordingly.As reported, the patient underwent placement of a trapease permanent inferior vena cava (ivc) filter.Per the medical records, the patient had a history of esophagectomy with complicated post-operative course, pulmonary embolism (pe) and gastrointestinal (gi) bleeding due to anticoagulation.The filter was therefore placed for pe prophylaxis.The filter was deployed in the infrarenal inferior vena cava (ivc) during the index procedure and the patient tolerated the procedure well with no reported complications.The following additional information received per the patient profile from (ppf) indicates that the device was unable to be retrieved although there have been no documented attempts made to retrieve the filter.The patient also reports to have coughed up blood, shortness of breath and severe anxiety.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis.A review of the device history record (dhr) associated with lot 15037530 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.
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