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Catalog Number RF320J |
Device Problems
Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
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Patient Problem
Death (1802)
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Event Date 06/07/2017 |
Event Type
Death
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Manufacturer Narrative
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Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately nine years post filter deployment, the patient scheduled for the filter retrieval.The filter was removed successfully but noted to be missing a metallic strut.Subsequent imaging revealed, a foreign body consistent with a metallic strut was identified overlying the left hemi thorax.The same the metallic object overlying the left hemi thorax in an unchanged location and position.The decision was made to not attempt retrieval of this metallic foreign object.Subsequently, a few days later patient expired.Therefore, the investigation is confirmed for the filter limb detachment.However, the investigation is inconclusive for the alleged perforation of the 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 the filter struts detached and perforated.The device was removed percutaneously.Further, it was reported that one strut of the ivc filter present in left lung and the detached strut was still overlying the left hemi thorax.The patient subsequently expired.
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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 struts detached and perforated.The device was removed percutaneously.Further, it was reported that one strut of the ivc filter present in left lung and the detached strut was still overlying the left hemi thorax.The patient subsequently expired.
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Manufacturer Narrative
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Manufacturing review: a device history review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately nine years post filter deployment, the patient scheduled for the filter retrieval.The filter was removed successfully but noted to be missing a metallic strut.Subsequent imaging revealed, a foreign body consistent with a metallic strut was identified overlying the left hemithorax.The same the metallic object overlying the left hemithorax in an unchanged location and position.The decision was made to not attempt retrieval of this metallic foreign object.Subsequently, a few days later patient expired.The death certificate was not received and an autopsy was performed and results showed that the patient died due to cocaine and fentanyl toxicity that lead to pulmonary edema and vascular congestion.Therefore, the investigation is confirmed for the filter limb detachment.However, the investigation is inconclusive for the alleged 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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Search Alerts/Recalls
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