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Catalog Number 466P306X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Embolus (1830); Hemorrhage/Bleeding (1888)
Event Date 12/01/2018
Event Type  Death  
Manufacturer Narrative
As reported, the patient had a clot formation during elective removal of a trapease vena cava filter that had been in place for thirteen years. The indication for the filter placement was not reported. The patient is reported to have had a history of end-stage renal disease on hemodialysis, failed graft kidney transplant in 2006, hepatic dysfunction, surgery, recurrent deep vein thrombosis (dvt), squamous cell carcinoma with severe vaginal neoplasia, lumbar vertebral osteomyelitis and coronary artery disease. The patient had been recently admitted with emphysematous cystitis. The reason for the elective trapease filter removal was not provided. Attempts to remove the filter via the right femoral vein and right jugular vein were initially unsuccessful with multiple wires and catheters used. The filter was finally captured with the use of simultaneous tension applied to wires looped around the superior and inferior aspects of the filter that had been advanced from both the femoral and the jugular access. This successfully collapsed the filter and the filter was snared from the right groin. The patient is also reported to have undergone removal of a tunneled small-bore catheter during the same setting. During the elective filter removal, the patient developed endothelial damage and bleeding with clot formation requiring treatment with a mechanical thrombectomy and thrombolysis. Given concerns for further bleeding, the patient was transferred to an inpatient bed. It is unclear from the report whether the patient was hypotensive when transferred. At some later point, the patient was started on a heparin infusion. Within hours of the initiation of the heparin, the patient developed hypotension requiring blood product administration. The patient sustained pulseless electrical activity (cardiac arrest) and subsequently expired. The patient¿s medical team believed that the patient ultimately expired from the development of an ivc clot that was able to embolize to her lungs (post ivc filter removal) causing a pulmonary embolism. They could not determine if the events could have been preventing by starting the heparin infusion earlier or not. The death was reported to have not been directly related to a defect in the equipment used during the case or of the ivc filter itself. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed. The trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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. Without procedural films for review, the reported intra-procedural clotting and endothelial damage events could not be confirmed and the exact cause could not be determined. The reported details indicate that the filter retrieval occurred thirteen years after implantation. The predominant concern is the development of endothelialization, which would make subsequent removal difficult. Endothelialization has been shown to lead to explantation problems after as short a period as twelve days. Perforation of the vessel wall, intimal tear, endothelial damage and/or bleeding are known complications. The patient¿s subsequent cardiac arrest and death appear to have been a result of result and ensuing sequelae. These events do not indicate a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Additionally, the trapease filter is designed for permanent implantation. Usage of the product other than that indicated in the product's instructions for use may involve additional risks not described in the labeling. Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
Event Description
As reported, the patient had a clot formation during elective removal of an ivc filter (filter had been in place for 13 years). The clot was retrieved during the interventional radiology procedure and heparin was administered. The patient was managed on an inpatient floor after the procedure with low systolic blood pressure (-100 mmhg), requiring blood products; she sustained a cardiac arrest and subsequently died. The death is not directly related to a defect in the equipment used during the interventional radiology case or with the ivc filter itself. The patient went for ivc filter removal, afterwards was hypotensive and bleeding requiring transfusion. During the procedure, after the ivc filter was removed, the endothelium was reported to have been damaged and a clot formed. The interventional radiologist/proceduralist was able to aspirate the clot, but the ir team was worried that the clot would reform quickly. Given bleeding and risk for continued bleeding, the inpatient medicine team struggled to make the determination if it was safe to initiate anticoagulation therapy immediately via a continual infusion or was it prudent to wait to allow the bleeding to be under better control. The patient was eventually started on anticoagulation (heparin) and within a couple of hours after starting the anticoagulation, the patient sustained a pulseless electrical activity arrest (pea) and died. The medicine team reported that they believed that the patient ultimately died from a pulmonary embolism related to being post-ivc filter removal. The medicine team outlined that the removal of the ivc led her to have a clot in her inferior vena cava that broke free and traveled to lungs. The medicine team did not initiate anticoagulation infusion immediately post-op when the patient arrived to the inpatient area bec use she was bleeding and hypotensive. In further discussion with the ir team, the ir/radiology team suggested that the anticoagulation be initiated despite the bleeding. There was ongoing communication between the "1\medicine" team and the ir/radiology team overnight (post-procedure), but it was not specifically clear which option regarding when to start the anticoagulation would be the best. It cannot be determined if this event ultimate event could have prevented by starting the anticoagulation infusion earlier, but this will be reviewed and discussed.
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Brand Name466P306X
Manufacturer (Section D)
cahir road
cashel, co.
Manufacturer (Section G)
cahir road
cashel, co.
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key8351237
MDR Text Key136525347
Report Number1016427-2019-02524
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2019,02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number466P306X
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/01/2019
Device Age13 YR
Event Location Hospital
Date Report to Manufacturer01/28/2019
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2019 Patient Sequence Number: 1