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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466F220A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Edema (1820); Embolus (1830); Occlusion (1984)
Event Date 12/26/2017
Event Type  Injury  
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly. As reported, the patient had an optease inferior vena cava (ivc) filter implanted. Per the medical records, the patient has a history of abdominal surgery for perforated viscus, pulmonary embolism (pe) with residual clot in the right popliteal vein and right heart strain. The filter was placed to prevent further pe due to the limited cardiac reserve. During the filter placement procedure, the filter was deployed over the l3 level without any complications. The patient tolerated the procedure well. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pe, cardiac arrhythmias post ivc filter implant resulting in two week hospitalization, and lower extremity edema. Per the patient profile form (ppf), the patient became aware of the alleged events two years and ten months post implantation. The patient reports blood clots, clotting and occlusion of the ivc and that the filter is unable to be retrieved. However, there have been no known attempts made to remove the filter. The patient also reports to be suffering from stress and anxiety. The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed. The optease 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. Blood clots, pe and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Cardiac arrhythmia does not represent a device malfunction and may be related to underlying patient related issues. Swelling of the lower extremities does not represent a device malfunction and may be related to underlying patient related issues. Anxiety does not represent a device malfunction and may be related to underlying patient related issues. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films or images for review the reported event(s) could not be confirmed. Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.
 
Manufacturer Narrative
Please note that the exact event date is unknown and that the event date is the complaint awareness date. As reported, the patient had an optease inferior vena cava (ivc) implanted. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pulmonary embolism, cardiac arrhythmias post ivc filter implant resulting in two week hospitalization, and lower extremity edema. 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. No additional information is available. The device was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. The inferior vena cava (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 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. Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such. Without medical records available for review, a clinical conclusion could not be determined as to the cause of the cardiac arrhythmias and leg swelling reported. There are possible patient and pharmacological factors that may have contributed to the reported event. 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. Please note that this is the initial/final report for this product.
 
Event Description
As reported through the legal department via a legal brief, the patient had an optease inferior vena cava (ivc) implanted. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pulmonary embolism, cardiac arrhythmias post ivc filter implant resulting in two week hospitalization, and lower extremity edema. 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. No additional information is available.
 
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Brand NameOPTEASE RETRIEVAL FILTER
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
MDR Report Key7213462
MDR Text Key273737845
Report Number1016427-2018-01086
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number466F220A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/26/2017
Event Location No Information
Date Manufacturer Received06/07/2018
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: 01/23/2018 Patient Sequence Number: 1
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