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Catalog Number UNK DENALI |
Device Problems
Occlusion Within Device (1423); No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Pain (1994); Swelling (2091); Thrombosis (2100); Thrombus (2101)
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Event Date 05/30/2015 |
Event Type
Injury
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Manufacturer Narrative
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No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The investigation of the reported event is currently underway.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 that two days after ivc filter placement to treat dvt in the right leg, the patient experienced an increase in the severity of the dvt including multiple pe.The patient further alleges that new clots started at the ivc filter and spread down both legs.The patient then alleges that they spent 14 days in icu and during that time 14 hours of interventional radiologic procedures were allegedly required to restore blood flow to the legs.The patient also alleges that there is ongoing swelling in their calves and pain.
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Manufacturer Narrative
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Manufacturing review: a lot history review was not performed as the lot number was not provided.Visual/microscopic inspection: a visual and microscopic inspection could not be performed as the device was not returned.Functional/performance evaluation: a functional and performance evaluation could not be performed as the device was not returned.Medical records review image/photo review: medical records were not provided.No images or photos were provided.Conclusion: the investigation is inconclusive for the reported event.Based upon the available information, the definitive root cause for this event is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.Deep vein thrombosis, pain.(b)(4).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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Search Alerts/Recalls
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