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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Occlusion Within Device (1423); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Coagulation Disorder (1779); Dyspnea (1816); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)
Event Date 07/05/2011
Event Type  Injury  
Manufacturer Narrative
The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported events thirty-four days post implantation. The patient also reports to be suffering from stress, anxiety, abdominal pain, shortness of breath, and pain in both legs. 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. According to the information received from the short form, the patient reports physical and emotional damages from blood clots, clotting, occlusion of the filter and resultant symptoms. As reported by the legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter. The indication for filter placement is not available. 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). As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which require or required medical care and treatment. The patient also reports to be suffering from stress, anxiety, abdominal pain, shortness of breath, and pain in both legs. According to the information received from the short form, the patient reports physical and emotional damages from blood clots, clotting, occlusion of the filter and resultant symptoms. The filter remains implanted; thus, unavailable for analysis. The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could 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. Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Anxiety, abdominal pain, shortness of breath and leg pain do 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. Should additional information become available, the file will be updated accordingly.
 
Manufacturer Narrative
Please note that the exact event date is unknown and that the event date in date of event is the complaint awareness date.   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. As a direct and proximate result of these malfunctions, the plaintiff suffered injuries and damages, which require or required medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer medical expenses, pain and suffering, and other damages. No additional information is available.   the product was not returned for inspection. Manufacturing records (dhr) could not be performed as the product catalog and lot number were not available.   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, clotting and occlusion of the ivc do not represent a device malfunction. The reported events could not be confirmed and the exact cause could not be determined; therefore no corrective actions 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 product.
 
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. As a direct and proximate result of these malfunctions, the plaintiff suffered injuries and damages, which require or required medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer medical expenses, pain and suffering, and other damages. No additional information is available.
 
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Brand Name466FXXXX
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 Key6629598
MDR Text Key252957827
Report Number1016427-2017-00362
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
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,Followup,Followup
Report Date 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/12/2017
Event Location No Information
Date Manufacturer Received08/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/09/2017 Patient Sequence Number: 1
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