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Model Number 466P306X |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
Perforation (2001)
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Event Date 12/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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Occupation: other, senior counsel, litigation.Additional information is pending and will be submitted in a follow up report when received.
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Event Description
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As reported by the legal brief, the patient underwent placement of an trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter perforation.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.
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Manufacturer Narrative
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As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of pulmonary embolisms and dvt.The trapease filter was deployed in the infrarenal inferior vena cava.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter perforation.Per the patient profile from (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, perforation of filter strut(s) outside the ivc.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.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.Should additional information become available, the file will be updated accordingly.
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Manufacturer Narrative
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Corrected data: product code.
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Manufacturer Narrative
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According to the information received in the patient profile from (ppf), the patient became aware of the reported events eight years and four months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, perforation of filter strut(s) outside the ivc.Information contained in the medical records indicated that the patient has a history of pulmonary embolisms and dvt.During the implant procedure, the patients right jugular vein was accessed.The trapease filter was deployed in the infrarenal inferior vena cava.The patient tolerated the procedure well.
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Search Alerts/Recalls
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