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Catalog Number RF400F |
Device Problems
Migration or Expulsion of Device (1395); Extrusion (2934); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); No Consequences Or Impact To Patient (2199); Blood Loss (2597)
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Event Date 08/15/2017 |
Event Type
Injury
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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 migration and 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.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 approximately eight years four months post vena cava filter deployment the filter was found to have migrated, perforated through the vena cava and penetrated into the l4 vertebral body.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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Event Description
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It was reported through the litigation process that approximately eight years four months post vena cava filter deployment the filter was found to have migrated, perforated through the vena cava and penetrated into the l4 vertebral body.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.New information: 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.Approximately 8 years 3 months later a ct venogram revealed that one of the filter strut perforated the l4 vertebrae.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced back pain and internal bleeding; however, the current 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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for filter migration and 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: 12/2011).
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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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eight years and three months post filter deployment, ultrasound reflex study bilateral legs scan revealed, no signs of deep vein thrombosis.Subsequently another ultrasound reflex study bilateral leg scan on the next day revealed, no sign of deep vein thrombosis.Eventually one week later, computed tomography (ct) revealed there was a bard g2 express inferior vena cava filter in place, with 1 of the legs penetrated the l4 vertebral body.There was no evidence for inferior vena cava thrombosis and acute ileal caval thrombus.There was narrowing of the left common iliac vein by the right common iliac artery, likely represented may-thurner syndrome.Therefore, the investigation is inconclusive for the alleged perforation of the ivc and filter migration.Based on the provided medical records, there is no clear evidence to confirm for perforation of the inferior vena cava (ivc) as it reported that 1 of the legs penetrated the l4 vertebral body.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: b6,d4(expiry date: 12/2011).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 approximately eight years four months post vena cava filter deployment the filter was found to have migrated, perforated through the vena cava and penetrated into the l4 vertebral body.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.New information: 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.Approximately eight years three months later a computed tomography (ct)venogram revealed that one of the filter strut perforated the l4 vertebrae.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced back pain and internal bleeding; however, the current status of the patient is unknown.
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Search Alerts/Recalls
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