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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Occlusion (1984); Thrombosis (2100); No Code Available (3191)
Event Date 05/12/2017
Event Type  Injury  
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly. As reported, 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 ivc. As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which require or required medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer medical expenses, pain and suffering, and other damages. The following additional information received per the patient profile form (ppf) indicates the patient experienced two strokes, three heart attacks, pain, and the patient is reported to continue to experience anxiety related to the device. The filter remains implanted; thus, unavailable for analysis. 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. Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Stroke and heart attach are known potential adverse events associated with the use of the ivc filter and are listed in the optease ifu. Anxiety and 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 comorbidities, specifically coagulopathy, 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
Additional information is pending and will be submitted within 30 days of 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. 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. As reported, a patient underwent placement of an optease vena cava filter. The information provided 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). The information received also indicated that the patient experienced two strokes, three heart attacks, blood clots in the right leg and pain, the patient is also reported to experience anxiety related to the device. The indication for the filter implant was morbid obesity with an elevated risk of pulmonary thromboembolism. The filter was placed via the right common femoral vein and deployed over the body of the l3 vertebrae. Post placement fluorogram confirmed god position and orientation. The patient tolerated the 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 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. Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. It was not reported it the strokes the patient experienced were embolic or hemorrhagic in nature. Myocardial infarction is associated with a disruption of flow to anyone of the coronary arteries that supply oxygenated blood to the heart. With the limited information provided it is not possible to determine what factors may have caused the reported events, however there are patient factors such as obesity that may have contributed to the events. Anxiety and 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 comorbidities, specifically coagulopathy, body habitus, pharmacological and lesion characteristics. A device malfunction has not been reported at this time. 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
As reported by the legal team, the plaintiff underwent placement of defendants¿ optease vena cava filter on or about (b)(6) 2008 in (b)(6). 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 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. The device was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made. The trapease 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. Thrombus in the filter does not represent a device malfunction. Thrombosis in the filter is a well-known potential complication. Factors that may have influenced the event include patient, pharmacological and lesion. 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.
 
Event Description
As reported by the legal team, the plaintiff underwent placement of defendants¿ optease vena cava filteron or about (b)(6) 2008 in (b)(6). 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 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.
 
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Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tp
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tp
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6617227
MDR Text Key268023393
Report Number1016427-2017-00350
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466F220A
Device Lot NumberR0608257
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 Received07/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2008
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: 06/07/2017 Patient Sequence Number: 1
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