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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 Problem Failure to Align (2522)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Injury (2348)
Event Date 02/29/2012
Event Type  Injury  
Manufacturer Narrative

The products were not returned for analysis. A review of the manufacturing records could not be conducted without a lot number.

 
Event Description

As reported by the legal team, plaintiff underwent placement of defendants' opteasc vcna cava filler on or about (b)(6) 2005. The filter subsequently malfunctioned and caused injury and damages, including, but not limited to, tilt of the ivc filter and embedded to wall of ivc. As a direct and proximate result of these malfunctions, plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

 
Manufacturer Narrative

As reported by the legal team, a patient underwent placement of an opteasce vena cava filler on or about (b)(6), 2005. The filter subsequently malfunctioned and caused injury and damages, including, but not limited to, tilt of the ivc filter and embedded to wall of ivc. 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. Without procedural films for review, the filter tilt reported could not be confirmed. With the limited information available for review, clinical factors contributing to the vessel injuries could not be determined as the timing and mechanism of the filter tilt is unknown at this time. 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.

 
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 an optease vena cava filter. The information received indicated that the filter subsequently malfunctioned and caused injury and damages, including, but not limited to tilt of the inferior vena cava (ivc) filter and it being embedded to wall of ivc. The following additional information contained in the patient profile from (ppf) indicated that the filter was unable to be retrieved although there have been no known attempts on records to remove the filter. The filter was noted to be tilted seven years and twenty-six days post implantation when the patient underwent a computerized tomography (ct) scan for ventral hernia pain. The patient also reports to be suffering from shortness of breath, chest pain, dizziness, leg swelling, anxiety and possible slow heart rate with dilatation of the ascending thoracic aorta. According to the medical records, the patient¿s pre-operative diagnosis was morbid obesity. The diameter of the ivc at the point of deployment was 28mm. The filter was successfully deployed into the distal ivc without difficulty. The filter did not migrate or rotate and the patient tolerated the index procedure well. 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 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 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 and embedded could not be confirmed. Clinical factors that may influenced any potential events include underlying patient co-morbidities, pharmacological and lesion characteristics. Anxiety, shortness of breath, dizziness, leg swelling, bradycardia and aortic dilation 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.

 
Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly. The following additional information received per the patient profile from (ppf) indicates that the filter was unable to be retrieved although there have been no known attempts on records to remove the filter. The filter was noted to be tilted seven years and twenty-six days post implantation when the patient underwent a computerized tomography (ct) scan for ventral hernia pain. The patient also reports to be suffering from shortness of breath, chest pain, dizziness, leg swelling, anxiety and possible slow heart rate with dilatation of the ascending thoracic aorta. According to the medical records, the patient¿s pre-operative diagnosis was morbid obesity. The diameter of the ivc at the point of deployment was 28mm. The filter was successfully deployed into the distal ivc without difficulty. The filter did not migrate or rotate and the patient tolerated the index procedure well. The device¿s expiration date is september 2007. A review of the manufacturing documentation associated with this lot (r1004294) presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
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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 Key6216348
MDR Text Key63663597
Report Number1016427-2016-00142
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 01/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466FXXXX
Device Catalogue Number466F220A
Device LOT NumberR1004294
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/05/2016
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2004
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: 12/30/2016 Patient Sequence Number: 1
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