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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER CATHETER, INTRAVASCULAR, DIAGNOSTIC

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CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 466P306X
Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolus (1830); Occlusion (1984); Swelling (2091); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)
Event Date 09/01/2016
Event Type  Injury  
Manufacturer Narrative
Initial reporter, occupation: other, senior counsel, litigation. Please note that the exact event date is unknown. As reported, 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 inferior vena cava filter thrombosis, inferior vena cava occlusion, venous insufficiency, leg swelling and pain. The ivc filter poses a progressive risk of perforation of surrounding vital organs, vessels and structures, which can result in severe pain and life-threatening complications. It also poses an ongoing and progressive risk of migration, fracture and embolization of a fracture causing serious injury and death. 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, and other damages. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. The inferior vena cava 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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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. A thrombosis noted in the device does not represent a device malfunction. Occlusion within the ivc does not represent a device malfunction. An occlusion within the vena cava or lower extremities may impede perfusion and cause venous insufficiency leading to possible swelling and pain of the lower extremities. However, given the limited information available for review at this time, there is nothing to suggest that the reported event is related to 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, 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 inferior vena cava filter thrombosis, inferior vena cava occlusion, venous insufficiency, leg swelling and pain. The ivc filter poses a progressive risk of perforation of surrounding vital organs, vessels and structures, which can result in severe pain and life-threatening complications. It also poses an ongoing and progressive risk of migration, m fracture and embolization of a fracture causing serious injury and death. 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, and other damages.
 
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Brand NameUNKNOWN TRAPEASE VENA CAVA FILTER
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
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 Key8289047
MDR Text Key134491495
Report Number1016427-2019-02466
Device Sequence Number0
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,Followup
Report Date 09/24/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
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 Received08/27/2019
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: 01/30/2019 Patient Sequence Number: 1
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