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Catalog Number RF048F |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2019 |
Event Type
Death
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Manufacturer Narrative
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Manufacturing review: a 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.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based on 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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Event Description
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It was reported through the litigation process that some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
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Manufacturer Narrative
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H10: manufacturing review: a 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 provided and reviewed.Post filter deployment, computed tomography of the abdomen revealed the filter was present within the infrarenal inferior vena cava.There was no abnormal tilt.Metallic struts course through the caval wall and to a large adjacent to the third portion of the duodenum and one was immediately adjacent to the aorta but did not course into the lumen.Other struts reside within the pericaval fat.The filter appears intact.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc).Based on 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: h6 (method, conclusion).H11: d4 (product catalog no), 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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Event Description
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It was reported through the litigation process that some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
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Search Alerts/Recalls
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