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Catalog Number UNKNOWN FILTER |
Device Problems
Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2013 |
Event Type
malfunction
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Manufacturer Narrative
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No medical images or medical records have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that during deployment of a vena cava filter, a filter limb was allegedly bent.Reportedly, there was no attempt to capture and retrieve the filter.The patient status was unknown.
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Manufacturer Narrative
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A complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for material deformation as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
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Event Description
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It was reported that during deployment of a vena cava filter, a filter limb was allegedly bent.Reportedly, there was no attempt to capture and retrieve the filter.The patient status was unknown.
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Manufacturer Narrative
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Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Medical records review: the patient had an ivc filter placed.Approximately four years post filter deployment, lumbar x-ray demonstrated an ivc filter with a bent arm on lateral views.On ap view, there was questions of an additional detached arm which could not be confirmed on additional views.Approximately one month later, dictated discharge summary reported that imaging revealed the ivc filter was displaced with projections beyond the inferior vena cava.Vascular surgery did not recommend any adjustments of the filter.Approximately six years post filter deployment, lower extremity ultrasound demonstrated residual nonocclusive thrombus from the common femoral vein to the popliteal vein bilaterally.Approximately three months later, the patient was admitted to the hospital with acute pancreatitis and alcohol withdrawal and was discharged approximately four days post hospital admission.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the provided medical records, the investigation can be confirmed for bent filter limb and perforation of the ivc.However, the investigation is inconclusive for filter limb detachment as the x-ray did not clearly indicate any detached limbs.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that during deployment of a vena cava filter, a filter limb was allegedly bent.Reportedly, there was no attempt to capture and retrieve the filter.The patient status was unknown.New information: medical records received and reviewed.Approximately four years post filter deployment, lumbar x-ray demonstrated an ivc filter with a bent arm on lateral views.Approximately one month later, imaging demonstrated the ivc filter was displaced with projections beyond the ivc.Vascular did not recommend any adjustments of the filter.The current status of the patient is unknown.
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Search Alerts/Recalls
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