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Catalog Number RF310F |
Device Problems
Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
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Patient Problem
Abdominal Pain (1685)
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Event Date 06/28/2017 |
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 the alleged perforation of the ivc and occlusion of the ivc filter as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.(expiry date: 01/2011).
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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 due to gunshot trauma.At some time post filter deployment, it was alleged that the filter occluded and the struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal 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 after nine years and two months of post filter deployment a computed tomography shows the struts of the filter penetrated the inferior vena cava.Three of the struts penetrated into a segment of jejunum.One strut touched the right lateral wall of the abdominal aorta.One strut touched the anterior cortex of a vertebral body.Therefore, the investigation is confirmed for perforation of inferior vena cava, however the investigation is inconclusive for occlusion.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: 01/2011), g3, g4.H11: h6 (method, results).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 due to gunshot trauma.At some time post filter deployment, it was alleged that the filter occluded and the struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.
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Search Alerts/Recalls
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