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Catalog Number 466P306X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative
Reporter. Occupation: other, senior counsel, litigation. As reported, the patient underwent placement of a trapease vena cava filter. The patient is reported to have had a recent history of extensive left lower deep vein thrombosis (dvt) and ongoing problems with the use of coumadin (including persistent nausea and dizziness). The indication for the filter placement was reported to have been as prophylaxis against pulmonary embolism (pe). The filter was implanted via the right femoral vein and placed in an infrarenal position. More than sixteen and a half years after the filter implantation, the patient became aware that filter strut(s) had perforated outside the inferior vena cava (ivc) and were associated with blood clots, clotting and/or occlusion of the ivc. The patient further reported having experienced mental anguish, worry and anxiety associated with the filter. 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 pe via percutaneous placement in the ivc 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 images or procedural films for review, the reported ivc perforation could not be confirmed and the exact cause could not be determined. A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters. Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation. Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction. Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics. The anxiety experienced by the patient does not represent a device malfunction. Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry. 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. Please note that this is the initial/final 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 perforation and occlusion. 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, suffering, distress and other damages. Additional information received per the medical records indicate that the patient had a history of extensive left lower extremity deep venous thrombosis one month prior to this procedure. The patient had ongoing problems with taking coumadin with side effects of persistent nausea and dizziness. The vena cava filter was implanted as prophylaxis against pulmonary embolism. The filter was deployed via the patient's right femoral vein. During the first attempt the guide wire preferentially went distally down the distal femoral vein. The guide wire and needle were then removed. A second venipuncture was then performed and the wire was steered into the iliac veins and the inferior vena cava. The filter was placed at the l2 level. A post procedural cavogram showed the filter was nicely centered and located just below the renal veins.   additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc. The patient continues to experience worry and anxiety. The patient became aware of the reported events sixteen years and six months after the index procedure.
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Manufacturer (Section D)
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key10165291
MDR Text Key195994628
Report Number1016427-2020-04034
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/17/2020 Patient Sequence Number: 1