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Model Number 466FXXXX |
Device Problems
Occlusion Within Device (1423); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)
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Event Date 06/04/2012 |
Event Type
Injury
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Manufacturer Narrative
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The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported by the legal department, the patient underwent placement of the optease vena cava filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis (dvt) and pulmonary embolism (pe).As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.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 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, pe, dvt and thrombosis within the filter and vasculature do not represent a device malfunction.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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Event Description
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As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis and pulmonary embolism.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, and pain and suffering, and other damages.
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Manufacturer Narrative
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Per the medical records, upon admission the patient underwent a computerized tomography of the chest which revealed a pulmonary embolism (pe) in the right lower lobe.The indication for filter placement was lower extremity deep vein thrombosis (dvt) and pe with impending cardiac surgery.The patient has history including moderate to severe mitral regurgitation (mr), recent percutaneous intervention (pci) for the coronary artery disease (cad), bilateral leg swelling, previous myocardial infarction (mi), gastric reflux, hypertension, hyperlipidemia, hypothyroidism, chronic obstructive pulmonary disease (copd), former smoker, skin cancer and umbilical hernia.During implantation of the inferior vena cava (ivc) filter via the right common femoral vein, an inferior vena cavogram was performed in order to depict the renal veins and to make sure they were in the vena cava.After that was done, it was made sure that the filter was positioned just below the position of the renal veins.Once that was localized, the filter was advanced and deployed without any complications.No immediate complications were noted.Approximately on or about one-month post implantation of the filter, the patient went on to have the mitral valve replacement (mvr) with coronary artery bypass grafting (cabg); however, the post-operative course was complicated with sternal wound dehiscence x 2 and surgical repair of the same.The patient also developed right pleural effusions that was treated with thoracoscopy.Approximately one month post mvr, the patient was admitted for pneumonia and sternal wound debridement and was treated accordingly.Sternal wound infection was diagnosed, and the patient was maintained on intravenous antibiotics over an extended time, had surgical debridement at pectoral flap repair.Over the course of the next eight months the patient continued to undergo multiple sternal wound debridements, to be treated with antibiotics and have a wound vac placed on the wound.In addition, approximately one year and one month post filter implantation, the patient was admitted for swelling and pain in the right upper extremity.A venous color duplex imaging was performed and revealed an acute deep vein thrombosis of the right upper extremity associated to picc line catheter.Oral anticoagulants were then initiated.Per the patient profile form (ppf), the patient became aware of the alleged events approximately on or about four years and one-month post implantation of the ivc filter.The patient reports blood clots, clotting and/or occlusion of the ivc, deep vein thrombosis (dvt) due to no circulation, and pulmonary embolism (pe) as well as a clogged filter.There have been no documented retrieval attempts.Approximately three days after the patient became aware of the alleged events, the patient reports having had a venous thrombectomy only to be done again the following day.The patient states to have been released from rehab sometime after.Also, the patient reports that their legs continue to be weak and was told that they would need to be on xarelto for life.The patient states that they continue to suffer from mobility, legs tired, and medicare d does not help much with xarelto.Additional information is pending and will be submitted within 30 days upon receipt.
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Manufacturer Narrative
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After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, upon admission the patient had a ct of the chest which revealed a pulmonary embolism (pe) in the right lower lobe.The indication for filter placement was lower extremity deep vein thrombosis (dvt) and pe with impending cardiac surgery.The patient has history including moderate to severe mitral regurgitation (mr), recent percutaneous intervention (pci) for the coronary artery disease (cad), bilateral leg swelling, previous myocardial infarction (mi), gastric reflux, hypertension, hyperlipidemia, hypothyroidism, chronic obstructive pulmonary disease (copd), former smoker, skin cancer and umbilical hernia.During implantation of the inferior vena cava (ivc) filter, the filter was positioned just below the renal veins.No immediate complications were noted.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis and pulmonary embolism.Per the medical records, approximately one-month post implantation of the filter, the patient had mitral valve replacement (mvr) with coronary artery bypass grafting (cabg); however, the post-operative course was complicated with sternal wound dehiscence x 2 and surgical repair of the same.The patient also developed right pleural effusions that were treated with thoracoscopy.Approximately one month post mvr, the patient was admitted for pneumonia and sternal wound debridement and was treated accordingly.Sternal wound infection was diagnosed, and the patient was maintained on intravenous antibiotics over an extended time, had surgical debridement at pectoral flap repair.Over the course of the next eight months the patient continued to undergo multiple sternal wound debridements, to be treated with antibiotics and have a wound vac placed on the wound.In addition, approximately one year and one month post filter implantation, the patient was admitted for swelling and pain in the right upper extremity.A venous color duplex imaging was performed and revealed an acute deep vein thrombosis of the right upper extremity associated to picc line catheter.Oral anticoagulants were then initiated.Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the ivc, deep vein thrombosis (dvt) due to no circulation, and pulmonary embolism (pe) as well as a clogged filter.The patient reports having had a venous thrombectomy done twice.Also, the patient reports that their legs continue to be weak and was told that they would need to be on xarelto for life.The patient reports poor mobility and tiredness of the legs.The filter remains implanted; thus, unavailable for analysis.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 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, pulmonary embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Weakness of the legs 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.Should additional information become available, the file will be updated accordingly.
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Manufacturer Narrative
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Section b5: additional information received per an amended patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), tilting of the filter and filter was embedded into the wall of the ivc. it was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused deep vein thrombosis (dvt) and pulmonary embolism (pe).Additional information received from the patient indicated that the patient became aware of the alleged events approximately four years post implant.The patient reports blood clots, clotting and/or occlusion of the ivc, dvt due to no circulation, and pe as well as a clogged filter.The patient further reported that there was perforation of the filter struts, the filter has tilted and is embedded in the wall of the inferior vena cava (ivc).Approximately three days after the patient became aware of the alleged events, the patient reports having had a venous thrombectomy only to be done again the following day.The patient also reports weak legs and that they will need to be on xeralto for life.According to the medical records, upon admission the patient underwent a computerized tomography of the chest which revealed a pe in the right lower lobe.The indication for filter placement was lower extremity dvt and pe with impending cardiac surgery.The patient¿s history was significant for moderate to severe mitral regurgitation, recent percutaneous intervention for the coronary artery disease, bilateral leg swelling, previous myocardial infarction, gastric reflux, hypertension, hyperlipidemia, hypothyroidism, chronic obstructive pulmonary disease, former smoker, skin cancer and umbilical hernia.The filter was placed via the right common femoral vein and deployed below the level of the renal veins.No immediate complications were noted.Approximately one-month post implant, the patient went on to have the mitral valve replacement with coronary artery bypass grafting; however, the post-operative course was complicated with sternal wound dehiscence x 2 and surgical repair of the same.The patient also developed right pleural effusions that were treated with thoracoscopy.Approximately one-month post valve replacement, the patient was admitted for pneumonia and infection of the sternal wound requiring debridement.Over the course of the next eight months the patient continued to undergo multiple sternal wound debridements, was treated with antibiotics and had a wound vac placed.Approximately one-year post implant, the patient was admitted for swelling and pain in the right upper extremity.A venous color duplex imaging was performed and revealed an acute dvt of the right upper extremity associated to picc line catheter.Oral anticoagulants were then initiated.There is currently no additional information available for review.There is currently no additional information available for review.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 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 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.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 12 days.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced clotting and/or occlusion include patient, procedural, pharmacological and lesion characteristics.Without procedural films or post implant imaging available for review, the reported filter tilt and perforation could not be confirmed nor a cause for the event(s) determined.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.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 and long-term complications associated with ivc filters.It is unknown if the tilt contributed to the reported perforation.Without implant or retrieval images available for review the reported events could not be confirmed or further clarified.With the limited information available for review it is not possible to draw a clinical conclusion between the device and the reported events.Weakness of the legs does not represent a device malfunction and may be related to underlying patient related 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.Corrected data section e2: non health professional.Section e3: occupation: other, litigation.
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