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Model Number UNKFILTER |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Calcium Deposits/Calcification (1758); Pain (1994); Anxiety (2328)
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Event Date 12/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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As reported, the patient underwent placement of an unknown cordis inferior vena cava (ivc) filter.The indication for filter placement is not available.Per the medical records, a ct scan, approximately 13 years post implant, revealed a cordis type ivc filter in normal position; no evidence of blood leak at the inferior vena cava region; no evidence of migration; no significant penetration; no localized hematoma and no retroperitoneal adenopathy, lumbar spondylosis with calcification of the abdominal aorta, and moderate-sized hiatal hernia.At the time, history included an unspecified injury to the inferior vena cava and abdominal pain.Per the patient profile form (ppf), the patient reports chronic obstructive pulmonary disease (copd), intestinal issues, deep vein thrombosis (dvt), pneumonia and anxiety related to 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 cordis vena cava filters are 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, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety and 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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Event Description
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As reported by the legal brief, the patient underwent placement of a unknown cordis vena cava filter.The patient is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment due to long term implant of the ivc filter.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside the patient's body.Per the medical records provided, approximately twelve years and eleven months after the index procedure, a cordis type inferior vena cava (ivc) filter was identified via an abdominal computerized tomography (ct) scan.At the time, the patient was reported to have a history of an unspecified injury to the inferior vena cava and abdominal pain.The ct report findings included a filter in normal position; no evidence of blood leak at the inferior vena cava region; no evidence of migration; no significant penetration; no localized hematoma and no retroperitoneal adenopathy.Incidental findings reported by the ct included a status post cholecystectomy without biliary duct dilatation; suggestion of possible previous weight loss surgery and a significant degree of lumbar spondylosis with calcification of the abdominal aorta with moderate-sized hiatal hernia.According to the information received in the patient profile form (ppf), a cordis type filter was identified via a ct scan.The patient reported a device defect that requires more follow up care, monitoring and treatment than normal because it is not functioning properly, and asserts to have suffered from chronic obstructive pulmonary disease (copd), intestinal issues, deep vein thrombosis (dvt), pneumonia and experienced anxiety related to the filter.The patient became aware of these events approximately twelve years and eleven months after the index procedure.
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Search Alerts/Recalls
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