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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Edema (1820); Occlusion (1984); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)
Event Date 07/13/2017
Event Type  Injury  
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly. It was reported that a patient underwent placement of a trapease vena cava filter. Information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc filter occlusion, severe lower extremity edema, collateral veins, legs turning black, and venous stasis. The following additional information received per the patient profile form (ppf) indicates the device was implanted due to a history of deep vein thrombosis. The patient was reported to have tolerated the index procedure well. The patient is reported to have experienced clotting, occlusion of the ivc, leg pain, device is unable to be retrieved, and continues to experience anxiety related to the device. The device was implanted via the right common femoral vein, with good position within the ivc and no procedural complications. The patient became aware approximately eleven and a half years later that the device malfunctioned. There is currently no additional information available. 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. Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction. Rather, patient and pharmacological factors may have contributed to these events. Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt). Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency. With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in edema, discomfort and discoloration of the affected extremity. Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed. Anxiety does not represent a device malfunction and may be related to underlying patient specific issues. With the limited information provided and no post implant imaging available for review it is not possible to establish a relationship between the reported events and the device. Given the limited information currently available for review, there is nothing to suggest that a malfunction in 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
As reported by the legal team, the patient underwent placement of the trapease vena cava filter on or about (b)(6) 2004. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc filter occlusion, severe lower extremity edema, collateral veins, legs turning black, 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 device was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made. 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. Ivc filter occlusion, severe lower extremity edema, collateral veins, legs turning black, and venous stasis does not represent a device malfunction. 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/or 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 team, the patient underwent placement of the trapease vena cava filter on or about (b)(6) 2004. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, ivc filter occlusion, severe lower extremity edema, collateral veins, legs turning black, 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 Name466P306X
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6763372
MDR Text Key263849267
Report Number1016427-2017-00492
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466P306X
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/13/2017
Event Location No Information
Date Manufacturer Received01/18/2018
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: 08/03/2017 Patient Sequence Number: 1
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