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Catalog Number EC500F |
Device Problems
Patient-Device Incompatibility (2682); Extrusion (2934)
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Patient Problems
No Consequences Or Impact To Patient (2199); Thrombosis/Thrombus (4440)
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Event Date 04/06/2018 |
Event Type
Injury
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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 alleged filter perforation 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 approximately five years five months post filter deployment a ct scan demonstrated the filter perforated and embedded.There were no reported attempts made to retrieve the filter.The status of the patient is unknown.
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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.Approximately five years and five months post filter deployment, a computed tomography scan demonstrated that the filter 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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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: b5, b6, b7, d4 (expiry date: 04/2015).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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Manufacturer Narrative
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Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.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, two years five months of post deployment, venogram revealed in the inferior vena cava there was a significant degree of thrombosis with minimum flow in the lateral aspect and also clots within the cone of the filter and clot extended above the filter.The patient underwent mechanical thrombectomy with the angiojet device and balloon angioplasty.Around, two years and eleven months later, computed tomography of the abdomen without contrast revealed the filter head was located approximately 2.3 cm below the level of the lowest left renal vein.A total of six distal prongs are identified coursing through the inferior vena cava wall consistent with perforation.Posterior prong was identified coursing toward the right upper vertebral body endplate of l3 vertebra with 5 mm course into the vertebral body.The inferior vena cava was contracted at the level of the filter and below the filter down to the confluence.The prongs are visualized perforated through the inferior vena cava by up to 2 cm for the longest most distal six prongs.Perforation appears shorter on the axial image, measures in anterolateral to the left prong perforation approximately 8 mm.Posterior lateral right perforation was approximately 8 mm.The long axis of the filter was parallel to the inferior vena cava.No filter fracture or displacement was appreciated.Therefore, the investigation is confirmed for the perforation of the inferior vena cava.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.Expiry date: 04/2015.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.Approximately five years and five months post filter deployment, a computed tomography scan demonstrated that the filter 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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