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Catalog Number RF048F |
Device Problems
Extrusion (2934); Patient Device Interaction Problem (4001)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for perforation 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.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 some time post vena cava filter deployment filter limbs perforated through the wall of the ivc, with one filter limb abutting the aorta.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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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, eleven years and ten months of post-deployment, computed tomography of the abdomen was revealed that an inferior vena cava filter was seen.Several of the filter struts penetrated the inferior vena cava wall.The strut at approximately 12:00 position measured approximately 1.5 mm from the inferior vena cava wall.The struts at 3:00 position measured approximately 2 mm from the inferior vena cava wall and touched the lateral wall of the aorta at approximately 3:00 position.The struts at the 10 o'clock position were approximately 2.3 mm from the inferior vena cava wall.The struts at 7:00 position were approximately 1 mm from the inferior vena cava wall.Most inferiorly, there was a strut at approximately 1:00 position which was approximately 2 mm away from the inferior vena cava wall.The 3:00 position structure was 5 mm away from the inferior vena wall contacted the aorta wall at 6:00 position.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.
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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 filter limbs perforated through the wall of the inferior vena cava, with one filter limb abutting the aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
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Search Alerts/Recalls
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