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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); Failure to Align (2522)
Patient Problems Pulmonary Embolism (1498); Edema (1820); Occlusion (1984); Swelling (2091); Thrombosis (2100)
Event Date 10/14/2014
Event Type  Injury  
Manufacturer Narrative
The following additional information received per the patient profile form (ppf) indicates that three years and two months post implantation, the filter was tilted. The unsuccessful filter removal attempt occurred five years and four months post implantation. The patient also reports to have pain, numbness due to swelling, pulmonary embolism (pe), multiple bilateral dvts, edema on both legs, and mental anguish. The filter was successfully deployed. As reported, the patient was implanted with an optease inferior vena cava (ivc) filter. The indication for filter implantation was dvt (deep vein thrombosis) and pe (pulmonary emboli). The filter was successfully deployed. Subsequently, the patient suffered deep vein thrombosis (dvt), blood clots, clotting, occlusion of the ivc filter, and the filter is unable to be retrieved. 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 suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The following additional information received per the patient profile form (ppf) indicates that three years and two months post implantation, the filter was tilted. The unsuccessful filter removal attempt occurred five years and four months post implantation. The patient also reports to have pain, numbness due to swelling, pulmonary embolism (pe), multiple bilateral dvts, edema on both legs, and mental anguish. The product was not returned for analysis as it remains implanted. A review of the device history record (dhr) associated with lot 15386963 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. The timing and mechanism of the filter tilt is unknown. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Without procedural films for review, the reported tilt and retrieval difficulty could not be confirmed and the exact cause could not be determined. Retrieval of the optease vena cava filter is indicated, in the us, up to 14 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. Endothelialization has been shown to lead to explantation problems after as short a period as 12 days. Blood clots, pulmonary embolism, and occlusive thrombosis within the filter do not represent a device malfunction. Pain, swelling of the legs and leg edema do not represent device malfunctions. 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. 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.
 
Manufacturer Narrative
The catalog code provided (b)(4) represents an unknown optease vena cava filter. The catalog and lot numbers for the actual product used in the procedure are unknown. The product is not available for analysis. The device history record review is not available as the sterile lot number is not available. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by the legal department in twigg vs. Cordis, the plaintiff was implanted with a cordis optease inferior vena cava (ivc) filter. Subsequently, the patient suffered deep vein thrombosis (dvt), blood clots, clotting, occlusion of the ivc filter, and the filter is unable to be retrieved. 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 suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages.
 
Manufacturer Narrative
Complaint conclusion- as reported by the legal department a patient was implanted with a cordis optease inferior vena cava (ivc) filter. Subsequently, the patient suffered deep vein thrombosis (dvt), blood clots, clotting, occlusion of the ivc filter, and the filter is unable to be retrieved. 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 suffered and will continue to suffer significant medical expenses, pain, 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 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 do not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Without procedural films for review, the reported filter retrieval difficulty could not be confirmed. The date of implantation and the attempted retrieval are unknown 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. Endothelialization has been shown to lead to explantation problems after as short a period as 12 days. 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 this is the final report.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
miami lakes FL
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
juarez
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6094762
MDR Text Key118006226
Report Number1016427-2016-00117
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2014
Device Model Number466FXXXX
Device Catalogue Number466F220A
Device Lot Number15386963
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/10/2016
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2011
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: 11/10/2016 Patient Sequence Number: 1
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