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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Chest Pain (1776); Embolus (1830); Occlusion (1984); Swelling (2091); Stenosis (2263); Vascular System (Circulation), Impaired (2572)
Event Date 09/20/2007
Event Type  Injury  
Manufacturer Narrative
The catalog number is unknown, if received, it will be provided. Complaint conclusion: as reported, the patient underwent placement of the trapease vena cava filter. The indication for the filter placement was not reported. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from 95 percent inferior vena cava (ivc) stenosis associated with the filter. The implanted filter is reported to pose a progressive risk of perforation of the vena cava and surrounding vital organs vessels and structures which can result in severe pain and life-threatening complications. It also poses an increased and progressive risk of migration, fractures. Embolization of a fracture, and thrombosis/clotting causing serious injury and death. The patient is forced to live with the possibility that these complications can happen at any moment which has led to severe fear stress anxiety and loss of enjoyment of life. 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, and other damages. 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 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. Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction. A protective ivc filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive). Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli. 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, 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 department, the patient underwent placement of the trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, emotional and physical damages from ninety-five percent inferior vena cava (ivc) stenosis associated with the ivc filter. The implanted filter noses in progressive risk of perforation of the vena cava and surrounding vital organs vessels and structures which can result in severe pain and life-threatening complications. It also poses an increased and progressive risk of migration, fractures. Embolization of a fracture, and thrombosis/clotting causing serious injury and death. The patient is forced to live with the possibility that these complications can happen at any moment which has led to severe fear stress anxiety and loss of enjoyment of life. 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, and other damages.
 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8430482
MDR Text Key139164872
Report Number1016427-2019-02628
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
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 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2005
Device Model Number466P306X
Device Catalogue Number466P306AU
Device Lot NumberR0402068
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 Received06/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2002
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/18/2019 Patient Sequence Number: 1
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