|
Catalog Number RF310F |
Device Problems
Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
|
Patient Problems
Pulmonary Embolism (1498); Pain (1994); Hematuria (2558)
|
Event Date 07/09/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
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: a sample evaluation could not be performed as the device was not returned.Images and medical records were not provided.The investigation is inconclusive for perforation of the ivc wall 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.(expiry date: 06/2012).
|
|
Event Description
|
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, it was alleged that the filter struts perforated the ivc.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced hematuria; however, the current status of the patient is unknown.
|
|
Manufacturer Narrative
|
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.Medical records were provided and reviewed.Approximately seven years and two months post filter deployment, computed tomography revealed small saddle embolus involving the right lower lobe without right heart strain.Approximately two months later, patient presented with chest pain.Subsequent computed tomography revealed pulmonary emboli in the left lower lobe.Approximately seven months later, computed tomography revealed inferior vena cava filter with prong protruding through inferior vena cava and one of the tines of the inferior vena cava filter contacts the right ureter, which could potentially cause hematuria.Approximately four months later, patient experienced abdominal pain.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).Additionally, it can be confirmed that the patient experienced pulmonary embolism 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: 06/2012 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.
|
|
Event Description
|
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, it was alleged that the filter struts perforated the inferior vena cava and into the ureter.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced hematuria; however, the current status of the patient is unknown.
|
|
Search Alerts/Recalls
|
|
|