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Catalog Number MD800F |
Device Problems
Migration or Expulsion of Device (1395); Malposition of Device (2616); Detachment of Device or Device Component (2907); Extrusion (2934)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/28/2017 |
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 approximately two years seven months post vena cava filter deployment a ct scan demonstrated that the filter perforated.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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical record was provided and reviewed.Approximately six months post filter deployment, ct revealed atherosclerosis of abdominal aorta, renal arteries, common iliac arteries and dilatation of the common bile duct.Approximately one year later, ct revealed filter tip 19 mm above the more inferior renal vein.There was no significant filter tilt or evidence of strut fracture or bending.A few struts minimally perforated into the adjacent fat.Therefore, the investigation is confirmed for perforation of the ivc.However, the investigation is inconclusive for filter tilt, filter migration and filter limb detachment.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: 04/2015), (device: 4001).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 two years seven months post vena cava filter deployment a ct scan demonstrated that the filter perforated.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.At some time post filter deployment, it was alleged that filter detached, perforated, tilted and migrated into inferior right renal vein.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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