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Catalog Number RF310F |
Device Problems
Malposition of Device (2616); Patient-Device Incompatibility (2682)
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Patient Problem
Pain (1994)
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Event Date 05/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged perforation of the inferior vena cava (ivc) and filter tilt as no objective evidence has been provided to confirm any alleged deficiency with the filter.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.
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Event Description
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It was reported through the litigation process that approximately eleven years and ten months post filter deployment, a computed tomography scan abdomen/pelvis reveals that the filter tilted, perforated through the inferior vena cava wall and in direct contact with the anterior aspect of the l3-4 intervertebral disc.The patient experienced unexplained lower back and abdominal pain, however the current status of the patient is unknown.
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Event Description
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It was reported through the litigation process that, approximately eleven years and ten months post filter deployment, a computed tomography scan of abdomen/pelvis reveals that the filter tilted, struts perforated through the cava wall and in direct contact with the anterior aspect of the l3-4 intervertebral disc.The patient experienced unexplained lower back and abdominal pain, however the current status of the patient is unknown.
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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 device was not returned for evaluation.Medical records were provided and reviewed.Approximately eleven years and ten months of post deployment, computed tomography with contrast showed angled inferior vena cava filter was noted with the superior most aspect below the renal veins by 46.8 mm.The length struts anteriorly and on the left extending beyond of the lumen.The filter was positioned within the patient¿s infra-renal inferior vena cava at the l3-4 level, just above caval bifurcation.The filter was severely tilted in the lateral direction at 23 degrees and the filter apex/hook was in direct contact with, and likely embedded in, the lateral wall of the inferior vena cava.The patient¿s infra-renal inferior vena cava measured 22 mm in maximum diameter at the level of the filter.Four of the filter¿s six legs (primary struts) perforated through the caval wall.Four of the filter¿s six arms (secondary struts) also perforate the inferior vena cava wall.Perforating medial struts directly impinge on the wall of adjacent aorta at the level of aortic bifurcation.A perforating posterior strut was in direct contact with the anterior aspect of the l3-4 intervertebral disc.Therefore, the investigation is confirmed filter tilt and perforation of the inferior vena cava (ivc).The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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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Search Alerts/Recalls
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