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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
Catalog Number 466F220A
Device Problems Fracture (1260); Occlusion Within Device (1423); Difficult to Remove (1528)
Patient Problems Pulmonary Embolism (1498); Occlusion (1984); Thrombosis (2100)
Event Date 01/04/2017
Event Type  Injury  
Manufacturer Narrative
The following additional information received per the patient profile form (ppf) indicates the device was implanted due to chronic bleeding with an inability to take anticoagulation and deep vein thrombosis (dvt. ) the index procedure is reported to have been a successful ivc filter insertion without difficulty. The optease filter is reported to have become occluded. A gunther tulip filter was reportedly placed above it. The gunther tulip filter reportedly perforated through the vena cava. Approximately 30 months after the optease filter was implanted an attempt was made to remove both filters. The gunther tulip was removed with difficulty. However the optease filter reportedly could not be retrieved. The patient is reported to have experienced tilting of the filter, clotting, occlusion of the ivc, and continues to experience anxiety related to the device. Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly. It was reported that a patient implantation of an optease filter. According to the information received the patient suffered post-implant pulmonary embolism, fracture of the filter, the filter ins embedded and is unable to be removed, filter occlusion, tilt, clotting and anxiety. The indication for the device implant was chronic bleeding and a deep vein thrombosis (dvt). The device was implanted via the right femoral vein without difficulty. At some point in time the optease filter became filled with clots and a gunther tulip filter was placed above it. It was reported that at an unknown time the gunther filter perforated the vena cava. Approximately two and a half years post optease implant a percutaneous attempt was made to remove both filters. The gunther filter was removed without difficulty, however; it was reported that the optease was embedded and fractured during the removal attempt and therefore was not removed. The information contained in the patient profile form also indicated that the patient experiences pain in her legs, at the location of the filter and anxiety. 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 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 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 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. Additionally, the timing and mechanism of the filter tilt is unknown. Without images or procedural films for review the reported tilt, occluded, clotting, fracture and embedded could not be confirmed. 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. 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 influenced any potential events include underlying patient co-morbidities, pharmacological and lesion characteristics. Anxiety and pain 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
The catalog code provided (466fxxxx), represents an unknown optease filter. The catalog and lot numbers for the actual product used in the procedure are unknown.     the device remains implanted in the patient and will not be returned for analysis. A device history record (dhr) review could not be conducted as a lot number was not provided. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by the legal department, the plaintiff was implanted with a cordis optease inferior vena cava (ivc) filter on or about (b)(6) 2014. Subsequently, the plaintiff suffered post-implant pulmonary embolism, fracture of the filter, and filter is unable to be removed.  as a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
 
Manufacturer Narrative
Complaint conclusion: as reported by the legal department, a patient had an optease inferior vena cava (ivc) filter implanted on or about (b)(6) 2014. Subsequently, the patient suffered post-implant pulmonary embolism, fracture of the filter, and filter is unable to be removed. 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. The instructions for use (ifu) notes recurrent vessel injury and/or pulmonary embolism as possible long-term complication associated with filter implantation. Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined. The reported event notes implantation of the filter on or about (b)(6) 2014; however, the attempted retrieval date is 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.
 
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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
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 Key6288694
MDR Text Key109983131
Report Number1016427-2017-00166
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,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2016
Device Catalogue Number466F220A
Device Lot Number16058491
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/04/2017
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/30/2017 Patient Sequence Number: 1
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