MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKFILTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2019

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.(b)(4).Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.

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 the patient being hospitalized for one month due to health complications and injuries related to the trapease filter.Approximately five years after the index procedure, the patient was hospitalized where she was required to undergo duodenal repair, reconstruction of the inferior vena cava (ivc) and removal of ivc filter.Although the form states that the filter was removed, it also states that the patient has continued to experience thrombosis in and below the trapease ivc filter causing pain, swelling, deep vein thrombosis (dvt), mental anguish and other injuries.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused the patient being hospitalized for one month due to health complications and injuries related to the trapease filter.Approximately five years post implant, the patient was hospitalized where and underwent duodenal repair, reconstruction of the inferior vena cava (ivc) and removal of ivc filter.Although the form states that the filter was removed, it also states that the patient has continued to experience thrombosis in and below the filter causing pain, swelling, deep vein thrombosis (dvt), mental anguish and other injuries.The indication for the filter placement, procedural details of the implant and removal and medical history of the patient have not been 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 ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava 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.Blood clots, clotting and/or occlusion of the inferior vena cava (ivc), vasculature or the filter do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filters are not indicated for use in the prevention of deep vein thrombosis.Duodenal repair and reconstruction of the ivc was reported; however, with the limited information provided a clinical conclusion cannot be made as to the contributing factors.Without procedural films, procedural details or post implant imaging available for review, the reported events could not be confirmed or further clarified.Swelling, pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11381380
• MDR Text Key: 233721708
• Report Number: 1016427-2021-04779
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKFILTER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Life Threatening