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Catalog Number UNK DENALI |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2016 |
Event Type
malfunction
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Event Description
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It was reported in an article titled "bard denali filter fractures", that a inferior vena cava filter was deployed successfully, in a patient with left iliofemoral deep venous thrombosis.Approximately four hundred and thirty two days later post filter deployment, the filter strut detached during retrieval of the filter.It was further reported that the detached strut and filter were retrieved with successive snaring.There was no reported patient injury.
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Manufacturer Narrative
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Bill s.Majdalany, minhajuddin s.Khaja, and david m.Williams, (2016).Bard denali filter fractures.Journal of vascular and interventional radiology, 27(7):1099-101.Doi: 10.1016/j.Jvir.2016.04.008.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.However, images were provided for review.The investigation of the reported event is currently underway.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.Device not returned.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the detachment could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: bill s.Majdalany, minhajuddin s.Khaja, and david m.Williams, (2016).Bard denali filter fractures.Journal of vascular and interventional radiology, 27(7): 1099-1101.Doi: 10.1016/j.Jvir.2016.04.008.H10: b5, g3 h11: h6 (result, conclusion) 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.H3 other text : device not returned.
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Event Description
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It was reported in an article in the "journal of vascular and interventional radiology" titled "bard denali filter fractures", that an inferior vena cava filter was deployed successfully in a patient after being diagnosed with left iliofemoral deep venous thrombosis.Approximately four hundred and thirty-two days post a vena cava filter deployment, the filter strut had allegedly detached within a centered filter during retrieval of the filter.Reportedly, the detached filter strut and the filter were retrieved with successive snaring.There was no reported patient injury.
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Search Alerts/Recalls
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