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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN OPTEASE VENA CAVA FILTER

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CORDIS CASHEL UNKNOWN OPTEASE VENA CAVA FILTER Back to Search Results
Model Number N/A
Device Problem Occlusion Within Device (1423)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Date 06/09/2017
Event Type  Injury  
Manufacturer Narrative
The following additional information received per the patient profile from (ppf) indicates that the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc). The patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress. According to the medical records, the indications for the procedure were a large pulmonary embolism (sub-massive) with evidence of right ventricular systolic dysfunction and dilatation and acute pulmonary hypertension. The patient had a history of syncope and was found to have severe bilateral pulmonary embolism with thrombus in the right pulmonary artery. The filter was successfully deployed at the level of the ivc below the renal veins. The patient tolerated the index procedure well and there were no reported complications. Corrected data:implant date. Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly. As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter. Per the medical records, the indications for the procedure were a large pulmonary embolism (sub-massive) with evidence of right ventricular systolic dysfunction and dilatation and acute pulmonary hypertension. The patient had a history of syncope and was found to have severe bilateral pulmonary embolism with thrombus in the right pulmonary artery. The filter was successfully deployed at the level of the ivc below the renal veins. The patient tolerated the index procedure well and there were no reported complications. The filter reportedly malfunctioned causing injury and damages to the patient including but not limited to caval thrombosis. As a direct and proximate result of these malfunctions, the patient reportedly suffered life- threatening injuries and damages, and required extensive medical care and treatment. The following additional information received per the patient profile from (ppf) indicates that the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc). The patient also reports to be suffering from emotional distress, mental anguish, anxiety and stress. 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 and thrombosis within the filter do not represent a device malfunction. 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. 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
(b)(6). Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available. ¿ if obtained, a follow up report will be submitted within 30 days upon receipt. As reported in the legal brief (b)(6) vs. Cordis, the patient underwent placement of an optease vena cava filter but the filter reportedly malfunctioned causing injury and damages to the patient including but not limited to caval thrombosis. ¿ as a direct and proximate result of these malfunctions, the patient reportedly suffered life- threatening injuries and damages, and required extensive medical care and treatment the product was not returned for analysis. A review of the manufacturing records could not be conducted without a lot number. 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. Caval thrombosis does not represent a device malfunction. The reported caval thrombosis could not be confirmed without films for review. Factors that may have influenced the event include patient, pharmacological and lesion characteristics. 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 in the legal brief (b)(6) vs. Cordis, the patient underwent placement of an optease vena cava filter but the filter reportedly malfunctioned causing injury and damages to the patient including but not limited to caval thrombosis. As a direct and proximate result of these malfunctions, the patient reportedly suffered life- threatening injuries and damages, and required extensive medical care and treatment.
 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6679727
MDR Text Key252154025
Report Number1016427-2017-00423
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
Report Date 01/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/09/2017
Event Location No Information
Date Manufacturer Received12/13/2017
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: 06/29/2017 Patient Sequence Number: 1
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