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Model Number 466P306AU
Device Problems Obstruction of Flow (2423); Unintended Movement (3026)
Patient Problem Coagulation Disorder (1779)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter. The patient is reported to have had a history of pulmonary embolism (pe) despite anticoagulation therapy. The patient presented to hospital with a recurrence of the pe. The indication for the filter placement was not reported. The filter was implanted via the right internal jugular vein and placed in an infrarenal position. The report noted that after the passage of a guidewire, a slight amount of extravasation that appeared to be subintimal was seen. Post-implant images revealed no evidence of hematoma or bleeding. The patient is reported to have tolerated the procedure well. More than fifteen years after the filter implantation, the patient became aware that the filter had tilted and associated clotting and occlusion of the filter along with bilateral lower extremity blood clots. The patient reported having undergone stenting of the filter and multiple surgeries. The patient further reported having experienced lower extremity swelling and severe pain, abdominal pain and anxiety associated with the filter. The product was not returned for analysis. A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. The trapease vena cava filter is indicated for use in the prevention of recurrent 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 images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Additionally, the timing and mechanism of the filter tilt is unknown. Blood clots, clotting and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction. Due to the nature of the complaint, the reported pain and swelling experienced by the patient could not be confirmed and the exact cause could not be determined. These clinical events do not represent evidence of a device malfunction. Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues 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.

Event Description

As reported by the legal brief, a patient underwent placement of a trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to tilting. As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages. Per the implant records, the patient was reported have a history of pulmonary embolism (pe). The right neck was prepped and draped in sterile fashion, and using ultrasound guidance, percutaneous access of the right internal jugular vein was accomplished. A guidewire was placed followed by the trapease introducer sheath, and under fluoroscopic visualization, the guidewire was passed into the infrarenal inferior vena cava. Injection of contrast gave good imaging of the vena cava, with a slight bit of extravasation, but it looked like it was just subintimal. A venacavogram was performed and visualized the position of the renal veins and positioned the trapease filter such that the apex was just inferior to the renal veins. The filter was deployed and positioned well. It did not migrate. Once it was deployed, placement of the filter was examined, and it looked to be well seated in the inferior vena cava beneath the renal veins. There was no evidence of hematoma formation nor evidence of bleeding. Blood loss was negligible. The patient was taken to the recovery room in satisfactory condition having tolerated the procedure without difficulty. According to the information received in the patient profile form (ppf), the patient reports tilting of the filter, becoming aware of this event approximately fifteen years and five months after the filter implantation. The patient further asserts to have suffered from blood clots in both legs post implant, resulting in stenting and multiple surgeries for filter clotting and occluding, in addition to severe pain and swelling of both legs, abdominal pain near the implant site, and experienced anxiety related to the filter.

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Manufacturer (Section D)
14201 nw 60th ave
miami lakes FL 33014 2802
Manufacturer (Section G)
14201 nw 60th ave
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014-2802
MDR Report Key12342133
MDR Text Key267258090
Report Number1016427-2021-05301
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device EXPIRATION Date12/31/2007
Device MODEL Number466P306AU
Device Catalogue Number466P306AU
Device LOT NumberR0105054
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/11/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 08/19/2021 Patient Sequence Number: 1