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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problems Filter (816); Difficult to Remove (1528); Retraction Problem (1536)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)
Event Date 07/01/2014
Event Type  Injury  
Manufacturer Narrative

It was reported that a patient underwent placement of the trapease vena cava filter. The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc filter collapsed and can no longer be retrieved. 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. There is currently no additional information available for review. 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 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. Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. 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. The information provided indicated that the filter collapsed. Without the procedural films and/or post-implant imaging available for review, the reported event could not be confirmed or further clarified, nor a cause or contributing factors be established. With the limited information provided it is not possible to establish a relationship between the reported events and the device. There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken. Should additional information become available, the file will be updated accordingly.

 
Event Description

As reported by the legal team, 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, ivc filter collapsed and can no longer be retrieved. 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 Name466P306X
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key7733396
MDR Text Key115523019
Report Number1016427-2018-01709
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466P306X
Device Catalogue Number466P306X
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2018
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? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/30/2018 Patient Sequence Number: 1
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