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Catalog Number 466F220A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Stenosis (2263); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
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Event Date 05/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter was associated with stenosis, caval thrombosis, and bleeding.In addition, the patient reported that the filter had become embedded and was associated with a complex removal procedure.Documented evidence of this filter retrieval procedure was not provided.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 optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (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 embedment could not be confirmed and the exact cause could not be determined.The predominant concern for embedding within 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.The optease retrievable vena cava filter is indicated for retrieval up to 23 days post-implantation.Following this period of time, and as early as twelve days, there is potential for endothelialization around the filter struts.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.Stenosis and/or thrombosis within the device or within the ivc and/or vasculature do not represent a device malfunction.Blood loss is a known potential adverse event associated to the filter device and may be related to the reported perforation.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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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Event Description
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As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to stenosis, caval thrombosis, bleeding, filter embedment and complex removal.Documented evidence of an attempt to retrieve the filter was not provided.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.
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Manufacturer Narrative
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As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused stenosis, caval thrombosis, bleeding, filter embedment and complex removal.The patient reported becoming aware of filter embedment, blood clots, clotting, occlusion of the ivc, stenosis and retroperitoneal bleed approximately four years and seven months post implant, at which time the filter was removed percutaneously.The patient indicated that after the removal procedure they were in the intensive care unit (icu) and then rehab due to inability to walk.Removal procedural details were not provided.The patient also reported anxiety related to the filter.According to the implant record the indication for the filter implant was deep vein thrombosis (dvt).The filter was placed via the right common femoral vein and deployed just below the renal veins.A confirmatory venogram showed excellent position of the filter and patent renal veins.There were no reported complications.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 optease 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.Blood clots, occlusive thrombosis and stenosis of the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Due to the nature of the complaint the reported thrombotic injuries could not be further clarified.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu 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 explant problems after as short a period as 12 days.Retroperitoneal bleed refers to an accumulation of blood found in the retroperitoneal space.This most often occurs due to a back-wall or high stick.Several risk factors that can contribute to bleeding complications associated with interventional procedures, include, but are not limited to advanced age, high or low bmi, vessels that are small in size, vessels scarred from previous surgeries, and vessels with presence of calcium/pad that may cause the patient to be at a higher risk.Additionally, procedural-related factors include procedure type (interventional), puncture site (high sticks, low sticks, back-wall sticks, side sticks and multiple sticks), anticoagulation therapy, glycoprotein (gpiib/iiia) therapy, and antithrombotic therapy.With the limited information provided a clinical determination could not be made.Anxiety and difficulty walking do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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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Event Description
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Per the implant records the patient was reported to have a preoperative diagnosis of deep vein thrombosis (dvt).The patient¿s right groin was prepped and draped in the usual sterile fashion, and a venous delivery sheath was inserted in the right common femoral vein using seldinger technique.A venogram performed identified the renal veins and the inferior vena cava (ivc) filter was deployed just below the renal veins.A confirmatory venogram showed excellent position of the filter and patent renal veins.There were no reported complications.According to the information received in the patient profile form (ppf), the patient reports filter embedment, blood clots, clotting, occlusion of the ivc, stenosis and retroperitoneal bleed, becoming aware of these events approximately four years and seven months after the filter implantation.The patient additionally reports undergoing percutaneous removal of the filter about four years and seven months after the filter was implanted, having to spend time in both intensive care unit (icu) and rehab due to inability to walk.Removal procedural detail were not provided.The patient further experienced anxiety related to the filter.
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Search Alerts/Recalls
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