Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive 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.
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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 not provided.Approximately, eight years and nine months of filter deployment, computed tomography of abdomen without contrast was performed for the patient with unspecified injury of the inferior vena cava which showed that there was an inferior vena cava filter properly positioned below the level of the renal veins.There was no tilting of the filter and no bending or breaking of the device.The distal anchoring struts extended minimally beyond the vessel wall.The impression of the study stated that filter complicated by a mild perforation of the distal anchoring struts.Therefore, the investigation is confirmed for 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.H10: b5, d4 (expiry date: 09/2011), g2,g3.H6 (method, conclusion).H10: d1,d4, h6 (device, result).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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It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombophlebitis and prior to two surgical-type procedures.Approximately, eight years and nine months post filter deployment, it was alleged that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.
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