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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)
Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Fatigue (1849); Occlusion (1984); Swelling (2091); Thrombosis (2100)
Event Date 01/27/2015
Event Type  Injury  
Manufacturer Narrative
The following additional information received per the patient profile from (ppf) indicates that the filter was unable to be retrieved six years and twenty eight days post implantation. Although the filter is reported to be unable to be retrieved, there have been no recorded attempts made to remove it. The patient reports to have had subsequent deep vein thrombosis (dvt), pulmonary embolism (pe). Six years and eight days post implantation, the patient presented with dyspnea on exertion and increased lower extremity swelling bilaterally and was found to have acute bilateral dvts and bilateral pe. Vascular surgery attempted thrombectomy with t-pa, as well as mechanical thrombectomy, which was partially successful. The left common femoral and iliac system are reported to have remained occluded, and the ivc filter did not clear of the clot at all, suggesting the chronic nature of the clot. The patient was recommended to be on lifelong anticoagulation. Since then, the patient has experienced difficulty with walking and suffers from shortness of breath and fatigue in the legs. According to the medical records, the patient¿s pre-operative diagnosis was pe. During the index procedure, the patient underwent interventional thrombolysis and the filter was then deployed without any reported complications. It was reported that a patient underwent placement of an optease vena cava. The information received indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc) and filter is unable to be removed. The following additional information received per the patient profile from (ppf) indicates that the filter was unable to be retrieved six years and twenty-eight days post implantation. Although the filter is reported to be unable to be retrieved, there have been no recorded attempts made to remove it. The patient reports to have had subsequent deep vein thrombosis (dvt), pulmonary embolism (pe). Six years and eight days post implantation, the patient presented with dyspnea on exertion and increased lower extremity swelling bilaterally and was found to have acute bilateral dvts and bilateral pe. Vascular surgery attempted thrombectomy with tissue plasminogen activator (t-pa), as well as mechanical thrombectomy, which was partially successful. The left common femoral and iliac system are reported to have remained occluded, and the ivc filter did not clear of the clot at all, suggesting the chronic nature of the clot. The patient was told that the filter could no longer be retrieved and that there were clots above and below the filter. The patient was recommended to be on lifelong anticoagulation. Since then, the patient has experienced difficulty with walking and suffers from shortness of breath and fatigue in the legs. According to the medical records, the patient¿s pre-operative diagnosis was pe. During the index procedure, the patient underwent interventional thrombolysis and the filter was then deployed without any reported complications. The product was not returned for analysis. A review of the device history record (dhr) associated with lot r0407213 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event. 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 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). Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such. Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics. Blood clots and thrombosis within the filter do not represent a device malfunction. Without the procedural films or post-placement imaging and the limited information provided, the report of 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. Difficulty walking, fatigue in the legs, swelling of the lower extremities, shortness of breath and anxiety do not represent a device malfunction and may be related to underlying patient specific issues. There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.
 
Manufacturer Narrative
Please note that the exact event date is unknown.   as reported through via a legal brief, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc and the filter. The filter is unable to be removed. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. No additional information is available. 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. Thrombosis and/or blood clots do not represent a device malfunction. It is possible that patient and/or pharmaceutical factors may have contributed to these concerns. Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined. Dates of implantation and attempted retrieval have not been reported 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. 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.   please note that this is the initial/final report for this file.
 
Event Description
As reported through the legal department via a legal brief, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, blood clots, clotting and occlusion of the ivc and the filter. The filter is unable to be removed. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. No additional information is available.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
miami FL
EI
MDR Report Key6389803
MDR Text Key283671052
Report Number1016427-2017-00215
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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 Received03/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466F220A
Device Lot NumberR0407213
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/16/2017
Event Location No Information
Date Manufacturer Received01/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/08/2017 Patient Sequence Number: 1
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