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Catalog Number EC500F |
Device Problems
Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
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Patient Problems
Injury (2348); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturing review: a device history review (dhr) review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided.Therefore, the investigation is inconclusive for filter tilt, perforation, and migration, 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.
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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 entirely migrated to heart, tilted and embedded in wall of the ivc and struts perforated into organs.The device was removed but the removal procedure was not provided.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: 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.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive for filter tilt, filter migration and perforation of the inferior vena cava (ivc) 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.H10: d4(expiry date: 09/2015).
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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 tilted, migrated to heart and embedded in wall of the ivc and struts perforated into organs.The device was removed.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 in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted, migrated to heart and embedded in wall of the ivc and struts perforated into organs.The device was removed.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4(expiry date: 09/2015).
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Search Alerts/Recalls
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