CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR
|
Back to Search Results |
|
Model Number 466P306AU |
Device Problem
Material Perforation (2205)
|
Patient Problem
Perforation of Vessels (2135)
|
Event Date 01/25/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Initial reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation of the filter.The patient reported becoming aware of perforation of filter struts outside the inferior vena cava, approximately eleven years and ten months post implant.The patient also reported mental anguish related to the filter.According to the implant record, the indication for the filter implant was recurrent deep vein thrombosis and pulmonary embolism.The filter was placed via the right internal jugular vein and deployed just above the vena cava bifurcation.The product was not returned for analysis and the sterile lot number provided is illegible; therefore, no device analysis nor device history record review could be performed.The trapease ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant imaging available for review, the reported filter perforation could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Please note that this is the initial report for this product.
|
|
Event Description
|
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter perforation.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.Additional information received per the medical records indicate that the patient has a history of recurrent deep vein thrombosis and pulmonary embolism.The filter was deployed via the patient's right side jugular vein using ultrasound guidance.The filter was successfully placed just above the vena cava bifurcation. additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava.The patient became aware of the reported events approximately eleven years and ten months after the index procedure.The patient also experienced psychological and mental anguish.
|
|
Search Alerts/Recalls
|
|
|