Catalog Number UNKNOWN G2 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
malfunction
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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 after an unknown amount of time post deployment of a vena cava filter, one of the filter limbs allegedly detached and was located in the pulmonary artery.There was no reported patient injury.No further information was provided.
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Manufacturer Narrative
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Manufacturing review: the product lot number was not provided; therefore, the device history records were not reviewed.Visual inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was not returned.Images and medical records were not provided.The investigation was inconclusive for the reported event.Based upon the available information, the definitive root cause was unknown.Labeling review: the current ifu (instructions for use) states: warnings: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Potential complications: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.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 after an unknown amount of time post deployment of a vena cava filter, one of the filter limbs allegedly detached and was located in the pulmonary artery.There was no reported patient injury.No further information was provided.
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Search Alerts/Recalls
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