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Catalog Number EC500J |
Device Problems
Extrusion (2934); Patient Device Interaction Problem (4001)
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Patient Problems
Death (1802); No Consequences Or Impact To Patient (2199)
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Event Date 03/04/2015 |
Event Type
Death
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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.Medical record review: vena cava filter was placed at l2/3 secondary to deep vein thrombosis of the right lower extremity.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.(expiry date: 02/2016); 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.At some time post filter deployment, it was alleged that the filter perforated the ivc wall.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: 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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately one year and five months post filter deployment, computed tomography (ct) revealed an inferior vena cava filter located at upper l2 to mid l3.Grade 1 perforation was noted.Subsequently the patient was expired.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc).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: b5, b6, d4(expiry date: 02/2016), g4, h4(02/2013) h11: b1, h1, h6(patient, 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.At some time post filter deployment, it was alleged that the filter perforated the patients inferior vena cava (ivc) wall.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.
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Search Alerts/Recalls
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