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Catalog Number MD800F |
Device Problems
Patient-Device Incompatibility (2682); Extrusion (2934)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Medical records review: the patient with left lower extremity deep vein thrombosis, difficult anticoagulation management, a lung mass and pending possible surgical intervention had a vena cava filter deployed using usual technique.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive for perforation of the ivc 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.Expiration date: 02/2014; manufacturing date: 02/2013.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 through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.The other reason for implant was, contradiction to anticoagulation.At some time post filter deployment, it was alleged that the filter struts perforated into the ivc.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and five months later post filter deployment, computed tomography of abdomen without intravenous contrast was performed which showed inferior vena cava filter appears appropriately positioned at the level of the lower pole of the right kidney.A filter strut appears to penetrate an adjacent small bowel loop and a second strut abuts or penetrates that loop as well.There was no inflammatory change in the adjacent mesenteric fat.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava.Based on 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.H10: d4(expiry date: 02/2014), g3.H11: g1, h6(device, method, conclusion).H11:section a through f - the information provided by bd 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 bd.
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Event Description
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It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and contradiction to anticoagulation.At some time post filter deployment, it was alleged that the filter struts perforated into the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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Search Alerts/Recalls
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