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Catalog Number RF048F |
Device Problems
Malposition of Device (2616); Detachment of Device or Device Component (2907)
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Patient Problem
Chest Pain (1776)
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Event Date 03/01/2007 |
Event Type
Injury
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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.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for alleged filter tilt and filter limb detachment 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 through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted and struts detached.The device has not been removed and there were no reported attempts made to retrieve the filter.It was further reported that the detached strut retained in lungs and the patient experienced chest pain; however, the current status of the patient is unknown.
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Event Description
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It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted and struts detached.The device has not been removed and there were no reported attempts made to retrieve the filter.It was further reported that the detached strut retained in lungs and the patient experienced chest pain; however, the current status of the patient is unknown.
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Manufacturer Narrative
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H10: 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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, one year and eleven months post deployment, x-ray of abdomen was performed for evaluation of positioning of the band which revealed an inferior vena cava filter was visualized and its axis was tilted.A laparoscopic band was seen, and the laparoscopic band was positioned and tilted in expected manner.Around, twelve years and five months later, a computed tomography of abdomen without contrast was performed which showed there was an inferior vena cava filter in place.Therefore, the investigation is confirmed for filter tilt.However, the investigation is inconclusive for filter limb detachment.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.H10: d4(expiry date: 10/2007),g2,g3,h6(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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Search Alerts/Recalls
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