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U.S. Department of Health and Human Services

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

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CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problem Difficult to Remove (1528)
Patient Problems Edema (1820); Embolism (1829); Occlusion (1984); Thrombosis (2100)
Event Date 03/23/2013
Event Type  Injury  
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly. As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter. Per the medical records, the patient has a history of bleeding, ulcerative colitis, deep vein thrombosis (dvt) and life-threatening pulmonary embolus while on anticoagulation. The filter was recommended as the patient was not a candidate for anticoagulation due to severe gastrointestinal (gi) bleeding. During the implantation procedure, the inferior vena cava (ivc) was measured to be 2 cm in diameter. The filter was deployed without any complications. A final venography showed acceptable filter placement. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, caval thrombosis, thrombosis/embolism, and the filter being unable to 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. Per the patient profile form (ppf), the patient had blood clots, clotting and occlusion of the ivc. The patient underwent an attempt to remove the filter forty-two days post implantation. The patient also reports the filter to be occluded and be suffering from mental anguish, anxiety and stress. Per the medical records, the indication for the removal procedure was severe bilateral lower extremity edema developed shortly after the filter implantation. During the removal procedure, the patient was noted to have a clot within the right common femoral vein with sluggish flow. 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. Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined. Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. The predominant concern is the development of endothelialization, which would make subsequent removal difficult. Endothelialization has been shown to lead to explantation problems after as short a period as 12 days. Blood clots, thrombosis, embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Edema of the lower extremities and anxiety do 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
Date of event was updated based on additional information provided. No further information was provided.
 
Manufacturer Narrative
The exact implant date is unknown. The catalog number is unknown, if received it will be provided. Complaint conclusion: as reported, the patient underwent placement of the optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, caval thrombosis, thrombosis/ embolism, and filter is unable to 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. 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 optease 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. Post procedural thrombosis and embolism are not related to a device malfunction. Clinical factors that may have influenced the events described include patient, pharmacological, lesion characteristics or other comorbidities. The legal brief also mentioned the inability to retrieve the ivc filter. The implantation date of the filter and the attempted retrieval date is unknown at this time. Retrieval of the optease vena cava filter is indicated up to 23 days post implantation. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. The predominant concern is the development of endothelialization, which would make subsequent removal difficult. Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days. 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 department, the patient underwent placement of the optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, caval thrombosis, thrombosis/embolism, and filter is unable to 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 Name466FXXXX
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 Key6935603
MDR Text Key267843415
Report Number1016427-2017-00686
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 other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
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 Received04/10/2018
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: 10/10/2017 Patient Sequence Number: 1
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