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Catalog Number 466P306X
Device Problem Unintended Movement (3026)
Patient Problem Perforation (2001)
Event Date 04/09/2021
Event Type  Injury  
Manufacturer Narrative

Occupation: other, senior counsel, litigation. Please note that the exact event date is unknown and the event date is the complaint awareness date. As reported, the patient underwent placement of a trapease vena cava filter. The patient is reported to have had a history of a stroke. The patient presented to hospital with right lower extremity pain and swelling. Diagnostic testing revealed deep vein thrombosis (dvt) from the right superficial femoral and extending down to the ankle; and possibly involving the popliteal vein. The indication for the filter placement was not reported. The filter was implanted via the right common femoral vein and placed in an infrarenal position. The patient is reported to have tolerated the procedure well and without complications. More than thirteen years after the filter implantation, the patient became aware that the filter had tilted and that filter struts had perforated into organs. The patient further reported having experienced anxiety and stomach problems associated with the filter. The patient also reported having had major surgeries, though the nature of these procedures and the association to the filter was not provided. 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 and organ perforation events 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. It is unknown if the tilt contributed to the reported perforation. 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. Due to the nature of the complaint, the reported stomach issues 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. 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 filter perforation and tilt. 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 and suffering, and other damages. Information received per the medical records indicate that the patient has a history of deep vein thrombosis involving the right superficial femoral vein (sfv) down to the ankle, pain in right leg, swelling in right leg and there also seemed to be some involvement with the popliteal vein. The filter was deployed via the patient's right common femoral vein. It was paced with the upper end at the upper l2 level. The patient tolerated the procedure without complications. Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt and perforation of filter struts into organs. The patient became aware of the reported events approximately thirteen years and five months after the index procedure. The patient also reported that they experienced stomach problems. The patient has had major surgeries and is anxious that another major surgery will be needed because of the filter.

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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 Key12349378
MDR Text Key267523017
Report Number1016427-2021-05321
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 08/20/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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 Received07/30/2021
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

Date Received: 08/20/2021 Patient Sequence Number: 1