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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
Coagulation Disorder (1779); Dyspnea (1816); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)
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Event Date 07/05/2011 |
Event Type
Injury
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Manufacturer Narrative
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Please note that the exact event date is unknown and that the event date in date of event is the complaint awareness date. as reported through the legal department via a legal brief, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc.As a direct and proximate result of these malfunctions, the plaintiff suffered injuries and damages, which require or required medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.No additional information is available. the product was not returned for inspection.Manufacturing records (dhr) could not be performed as the product catalog and lot number were not available. 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, clotting and occlusion of the ivc do not represent a device malfunction.The reported events could not be confirmed and the exact cause could not be determined; therefore no corrective actions will be taken.Should additional information become available, the file will be updated accordingly. please note that this is the initial/final report for this product.
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Event Description
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As reported through the legal department via a legal brief, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc.As a direct and proximate result of these malfunctions, the plaintiff suffered injuries and damages, which require or required medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.No additional information is available.
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Manufacturer Narrative
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The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported events thirty-four days post implantation.The patient also reports to be suffering from stress, anxiety, abdominal pain, shortness of breath, and pain in both legs.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.According to the information received from the short form, the patient reports physical and emotional damages from blood clots, clotting, occlusion of the filter and resultant symptoms.As reported by the legal brief, the patient underwent placement of an optease inferior vena cava (ivc) 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, blood clots, clotting and occlusion of the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which require or required medical care and treatment.The patient also reports to be suffering from stress, anxiety, abdominal pain, shortness of breath, and pain in both legs.According to the information received from the short form, the patient reports physical and emotional damages from blood clots, clotting, occlusion of the filter and resultant symptoms.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety, abdominal pain, shortness of breath and leg pain do 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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After further review of additional information received the following sections date rec¿d by mfr, type of report, if follow-up what type, and event problem and evaluation codes have been updated accordingly.As reported, the patient underwent placement of an optease inferior vena cava (ivc) 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, blood clots, clotting and occlusion of the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which require or required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported events thirty-four days post implantation.The patient also reports to be suffering from stress, anxiety, abdominal pain, shortness of breath, and pain in both legs.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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 and thrombosis within the filter and vasculature do not represent a device malfunction.Shortness of breath, pain in the legs and abdomen do not represent device malfunctions and may be related to underlying patient issues.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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Manufacturer Narrative
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As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of pulmonary embolism (pe) with subdural hematoma.The indication for the filter placement was not reported.Thirty-four days after the filter implantation, the patient became aware that the filter was associated with blood clots, clotting and/or occlusion of the inferior vena cava (ivc).In addition, the patient reported that device was occluded and that six filter strut(s) had perforated into the ivc wall; with one strut into the aorta.The patient further reported having experienced stress, anxiety, abdominal pain, shortness of breath and pain in both legs, severe symptomatic right leg deep vein thrombosis (dvt) associated with the filter.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 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 images or procedural films for review, the reported filter tilt, ivc perforation and aortic perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.A dvt occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.These events do not represent a malfunction of the device.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Due to the nature of the complaint, the reported shortness of breath abdominal and leg pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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, mental anguish, fear, 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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Search Alerts/Recalls
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