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Model Number 466FXXXX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Coagulation Disorder (1779); Dyspnea (1816); Nausea (1970); Occlusion (1984); Swelling (2091); Thrombosis (2100); Anxiety (2328)
Event Date 06/29/2018
Event Type  Injury  
Manufacturer Narrative
The product remains implanted and is thus not available for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Additional information is pending and will be submitted within 30 days upon receipt.
Event Description
As reported by the legal department, the patient underwent placement of the optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to blood clots, clotting, and/or occlusion of the ivc and inability to retrieve the filter (unknown retrieval attempt was made). The following additional information received per the medical records indicate that the patient underwent placement of an 6fr optease vena cava filter via the right femoral vein for a massive pulmonary embolus. Approximately six years later, the patient was diagnosed with an occluded ivc filter and bilateral deep vein thrombosis. The patient was not on chronic anticoagulation at that time. The patient was later discharged on coumadin. Approximately two years later, the patient reported extreme heaviness and ¿bursting pressure¿ in his legs, shortness of breath and nausea when walking short distances. The patient was noted to have acute on chronic embolism and thrombosis of the ivc, saddle embolus of the pulmonary artery (without acute cor pulmonale) and bilateral lower extremity edema. The ivc occlusion extended from just below the renal veins, through the ivc filter and to the common femoral veins. The patient was deemed to be a poor surgical candidate and underwent caval and iliac venography with recanalization and stenting (24x45mm boston scientific wallstent) of a chronically occluded vena cava. In addition, recanalization and stenting of chronically occluded right (3 wallstents placed) and left (4 wallstents placed) common and external iliac veins. According to the information received in the patient profile from (ppf), the patient is reported to have experienced blood clots, clotting, and/or occlusion of the ivc, embedment of the filter in the wall of the ivc and an inability to retrieve the device (filter removal was not attempted). The patient is reported to have become aware of the alleged filter failure in the late spring of 2016. Additionally, the patient suffers from severe pain and swelling from blood clots in both legs. As a result, the patient is reported to be confined to a wheelchair. The patient underwent stent placement due to the occlusion of the filter. Furthermore, the patient suffers from mental anguish regarding the current status of the filter, stents and any additional injury that may be caused as a result of the filter. Because the filter remains implanted, the patient will continue to suffer significant medical expenses, pain and suffering, and other damages.
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Brand Name466FXXXX
Manufacturer (Section D)
cahir road
cashel, tipperary 00000
EI 00000
Manufacturer (Section G)
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key8109934
MDR Text Key128567439
Report Number1016427-2018-02319
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/28/2018 Patient Sequence Number: 1