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Model Number 466FXXXX |
Device Problems
Occlusion Within Device (1423); Difficult to Remove (1528); Failure to Align (2522)
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Patient Problems
Pulmonary Embolism (1498); Edema (1820); Occlusion (1984); Swelling (2091); Thrombosis (2100)
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Event Date 10/14/2014 |
Event Type
Injury
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Manufacturer Narrative
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The catalog code provided (b)(4) represents an unknown optease vena cava filter.The catalog and lot numbers for the actual product used in the procedure are unknown.The product is not available for analysis.The device history record review is not available as the sterile lot number is not available.Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported by the legal department in twigg vs.Cordis, the plaintiff was implanted with a cordis optease inferior vena cava (ivc) filter.Subsequently, the patient suffered deep vein thrombosis (dvt), blood clots, clotting, occlusion of the ivc filter, and the filter is unable to be retrieved.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 suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages.
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Manufacturer Narrative
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Complaint conclusion- as reported by the legal department a patient was implanted with a cordis optease inferior vena cava (ivc) filter.Subsequently, the patient suffered deep vein thrombosis (dvt), blood clots, clotting, occlusion of the ivc filter, and the filter is unable to be retrieved.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 suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed. the optease 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 do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films for review, the reported filter retrieval difficulty could not be confirmed.The date of implantation and the attempted retrieval are unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.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 explantation problems after as short a period as 12 days.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.Please note this is the final report.
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Manufacturer Narrative
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The following additional information received per the patient profile form (ppf) indicates that three years and two months post implantation, the filter was tilted.The unsuccessful filter removal attempt occurred five years and four months post implantation.The patient also reports to have pain, numbness due to swelling, pulmonary embolism (pe), multiple bilateral dvts, edema on both legs, and mental anguish.The filter was successfully deployed.As reported, the patient was implanted with an optease inferior vena cava (ivc) filter.The indication for filter implantation was dvt (deep vein thrombosis) and pe (pulmonary emboli).The filter was successfully deployed.Subsequently, the patient suffered deep vein thrombosis (dvt), blood clots, clotting, occlusion of the ivc filter, and the filter is unable to be retrieved.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 suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages.The following additional information received per the patient profile form (ppf) indicates that three years and two months post implantation, the filter was tilted.The unsuccessful filter removal attempt occurred five years and four months post implantation.The patient also reports to have pain, numbness due to swelling, pulmonary embolism (pe), multiple bilateral dvts, edema on both legs, and mental anguish.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot 15386963 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.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 tortuousness.Without procedural films for review, the reported tilt and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.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 explantation problems after as short a period as 12 days.Blood clots, pulmonary embolism, and occlusive thrombosis within the filter do not represent a device malfunction.Pain, swelling of the legs and leg edema do not represent device malfunctions.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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Search Alerts/Recalls
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