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, in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that filter detached, perforated, migrated, tilted and embedded in the wall of inferior vena cava.The device was removed percutaneously.The current status of the patient is unknown.
|
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 and in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted, migrated, struts detached and perforated.The device was removed percutaneously.The current status of the patient is unknown.
|
H10: 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 eleven years and ten months later, computed tomography angiography of the chest revealed that there was no evidence of pulmonary embolus.Small pericardial effusion.Inferior vena cava filter fragment was in a distal branch of the right middle lobe pulmonary artery.X-ray of abdomen anteroposterior portable was performed, which showed no evidence of obstruction.Inferior vena cava filter with 2 apparently fractured limbs.Patient endorsed sudden onset substernal and left-sided chest pain.Two additional legs protruded through inferior vena cava wall but not fractured.After four days, computed tomography venogram was performed prior to filter removal intervention.Venogram was notable for piece of inferior vena cava filter lodged in right ventricle.Ultrasound showed an anechoic and compressible right internal jugular vein and right common femoral vein.Multiple fractured recovery inferior vena cava filter.Four arms were fractured from the filter body.One of these was in the right middle lobe in a distal pulmonary artery branch.Another was in the free wall of the right ventricle.One was adherent to the caval wall by the filter and the other was trapped within the filter.Real-time ultrasound guidance was used to puncture the right internal jugular vein.Multiple spot images of the filter were performed.Because of concern about the free fragment within the filter, cavography was not performed.The filter fragment and filter were removed together using endobronchial forceps in the jaws of life technique.Endobronchial forceps were then used to free the wall adherent fractured filter arm from the inferior vena cava and this fragment was removed.Post removal cavogram was performed.Next, real-time ultrasound guidance was used to puncture the right common femoral vein.Selective right pulmonary arteriography was performed.Superselective catheterization of the right middle lobe branch containing the filter fragment was performed and further diagnostic arteriography carried out.The fragment was then removed using a white set and a 5mm snare.Pulmonary arteriography was repeated.Next, a pigtail catheter was placed in the right ventricle and right ventricle artery performed.Using an agilis sheath, transfemoral attempt was made to remove the filter fragment from the right ventricular free wall.Because the angle was unsatisfactory for this, the jugular approach was again used by the existing sheath.Using a combination of the agilis sheath and a 20mm snare, the fragment was captured and removed.Right ventriculography was repeated.Limited ultrasound of the heart was performed to exclude increase in pericardial effusion.The sheaths were then removed, and hemostasis was gained by manual compression.Successful complex filter removal of multiply fractured and embolized filter.After removal, the cavogram was normal except for minimal spasm.The filter was inspected and found to be removed in its entirety, noted it was in 5 pieces.Therefore, the investigation is confirmed for alleged filter limb detachment, filter migration and perforation of the inferior vena cava (ivc).However, the investigation is inconclusive for alleged filter tilt.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.H10: d4 (expiry date: 06/2007), g4, h6(device: 4001).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.
|