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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 Occlusion Within Device (1423)
Patient Problems Coagulation Disorder (1779); Edema (1820); Occlusion (1984)
Event Date 11/11/2016
Event Type  Injury  
Manufacturer Narrative
The catalog number is unknown, if received it will be provided. The exact filter implantation date is unknown. 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, blood clots, clotting and occlusion of the ivc filter, thrombus in ivc, chronic left extremity edema, and venous stasis. 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 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 occlusion of the ivc filter does not represent a device malfunction. Also mentioned in the brief was edema and venous stasis. Venous stasis is a condition of slow blood flow in the veins. This venous insufficiency is sometimes caused by dvt and high blood pressure inside the veins. Clinical factors that may have influenced the reported events include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation or malfunction of the filter. Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for 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, manufacturing process or implantation of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
 
Manufacturer Narrative
As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter. The indication for the filter was placed as treatment for continuing deep venous thrombosis (dvt) in left leg and pulmonary embolism (pe) despite therapeutic anticoagulation. Per the medical records the patient tolerated the index procedure well. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and occlusion of the ivc filter, thrombus in ivc, chronic left extremity edema, and venous stasis. 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 patient is reported to continue to experience anxiety related to the device. The filter remains implanted; thus, unavailable for analysis. The product was not returned for analysis. A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. 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, thrombosis a d occlusive thrombus within the filter do not represent a device malfunction. Venous stasis and chronic edema of the legs do not represent device malfunctions and maybe related to the underlying disease process that was the indication for filter placement. 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. Should additional information become available, the file will be updated accordingly.
 
Manufacturer Narrative
The catalog number is unknown, if received, it will be provided. The exact filter implantation date is unknown. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Additional information will be submitted within 30 days of receipt.
 
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, blood clots, clotting and occlusion of the ivc filter, thrombus in ivc, chronic left extremity edema, and venous stasis. 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 Key6965078
MDR Text Key117748891
Report Number1016427-2017-00703
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,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466F220A
Device Lot NumberR0807219
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 Received11/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2007
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: 10/20/2017 Patient Sequence Number: 1
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