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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE VENA CAVA FILTER

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CORDIS CASHEL OPTEASE VENA CAVA FILTER Back to Search Results
Model Number N/A
Device Problem Occlusion Within Device (1423)
Patient Problems Embolus (1830); Occlusion (1984); Perforation of Vessels (2135); Anxiety (2328)
Event Date 05/17/2017
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 implantation of an optease inferior vena cava (ivc) filter. The patient became aware approximately five and a half years later that the device had tilted, perforated the ivc had blood clots and occlusion of the filter. Additional information received in the patient profile form (ppf) indicated that the patient is also experiencing pain, swelling and numbness in the left leg, chest pain, abdominal pain, and continues to experience anxiety related to the device that is being treated with medication. The indication for the device implant was pending gastric bypass surgery for morbid obesity. The device was placed via the right internal jugular vein. Vena cava-gram showed a widely patent ivc with no evidence of thrombus, reflux f contrast into both iliac venous systems and the renal veins had good visualization and no evidence of thrombus in iliac veins. Post implant vena-gram noted good apposition of the filter to the wall of the ivc, reflux of contrast into both iliac veins and good visualization of the renal veins. There is currently no additional information available. 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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation. Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. 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 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, resulting in swelling/edema/bulging of the effected extremity(s). Blood clots, thrombosis in the filter and occlusion of the ivc do not represent a device malfunction, rather clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics. The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event. It is unknown if the tilt contributed to the reported perforation. A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. Without the procedural films or post-placement imaging and the limited information provided, the report of tilt, perforation, thrombosis, blood clots, clotting and occlusion of the inferior vena cava (ivc) filter could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn. Pain, swelling and numbness of the left lower extremity, chest and abdominal pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues. Given the limited information currently available for review, 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
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 jordan vs. Cordis, an unspecified period of time after an optease vena cava filter was implanted, the filter reportedly malfunctioned causing injury and damages including but not limited to blood clots, clotting, occlusion, and perforation of the ivc. As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required 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. Clots, blood clots, occlusion and perforation do not represent a device malfunction. The reported events 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 jordan vs. Cordis, an unspecified period of time after an optease vena cava filter was implanted, the filter reportedly malfunctioned causing injury and damages including but not limited to blood clots, clotting, occlusion, and perforation of the ivc. As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment.
 
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Brand NameOPTEASE VENA CAVA FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
miami FL
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
miami FL
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6615051
MDR Text Key268914610
Report Number1016427-2017-00349
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 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number466F220A
Device Lot Number15385970
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/17/2017
Event Location No Information
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/06/2017 Patient Sequence Number: 1
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