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Catalog Number 466P306X
Device Problems Difficult to Remove (1528); Unintended Movement (3026)
Patient Problems Pain (1994); Injury (2348); Numbness (2415); Nodule (4551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/01/2018
Event Type  Injury  
Manufacturer Narrative
Reporter occupation: other, senior counsel, litigation. As reported, the patient underwent placement of a trapease vena cava filter. The indication for the filter placement was not reported. At some point after the filter implantation, the patient became aware that the filter had tilted. 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 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. 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 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 tilt of the filter and the resultant symptoms. 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, and pain and suffering, loss of enjoyment of life and other damages. Additional information received per the medical records indicate that the patient has a history of hypertension. Approximately six months prior to implantation of the filter, the patient had a cholecystectomy procedure performed. Additional information received per the patient profile form (ppf) states that the patient experienced tilt of the filter. The patient became aware of the reported event approximately eight years and eleven months after the index procedure. The patient also experienced numbness in the extremities and back pain. Approximately nine years and four months after the index procedure a computed tomography (ct) scan was done to assess the inferior vena cava filter. The scan revealed the filter to be tilted. No strut fracture was noted and no inferior vena cava stenosis was noted. Incidental findings of fatty liver and lung nodule are noted.
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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 Key11125341
MDR Text Key225542450
Report Number1016427-2021-04698
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2021 Patient Sequence Number: 1