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Catalog Number EC500J |
Device Problems
Migration or Expulsion of Device (1395); Extrusion (2934); Patient Device Interaction Problem (4001)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the filter perforation and migration as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon 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.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 through the litigation process that some time post vena cava filter deployment a ct scan demonstrated the filter perforating and migrating.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately, five years ten months of post deployment, computed tomography of the abdomen and pelvis was revealed the filter was noted with the tip projected at the l2-l3 disc space level.The filter was oriented parallel the course of the inferior vena cava without abnormal tilt of the inferior vena cava.The metallic struts are intact.The tip of the filter was not abutted the caval wall and located approximately 1.7 mm from the medial wall.The tip was located 3.9 cm below the confluence of the right renal vein with the inferior vena cava.Mild caval perforation of several struts was noted measuring 3.9 mm in maximum length involving one of the posteromedial struts towards the patient's left.The tip of this struts was located 2.5 mm posterolateral to the aorta, but no involvement of the aorta, small bowel or other abdominal organs was noted.Caval perforation of a posterolateral struts towards the patient's left measures 3.8 mm with extension into the adjacent annular fibers of the l4-l5 disc.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for filter migration.Based upon 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.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 a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment a ct scan demonstrated that filter migrated and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
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Search Alerts/Recalls
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