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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 Difficult to Remove (1528); Defective Component (2292); Unintended Movement (3026)
Patient Problems Coagulation Disorder (1779); Edema (1820); Occlusion (1984); Thrombosis (2100); Injury (2348); No Code Available (3191)
Event Date 10/09/2013
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient underwent placement of the optease filter. The information received indicated that the filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, inferior vena cava (ivc) breakage, filter migration, collapse of the inferior vena cava around the filter, the ivc filter being thrombosed, chronic deep vein thrombosis (dvt) and subsequent clots leading to chronic edema. As a direct and proximate result of these malfunctions, there were two percutaneous attempts performed to remove the filter. The patient underwent the first attempt to remove the filter three years and seven months post implantation. The second attempt was made thirty-three days after that, however; it is unclear if the filter was actually removed during the second attempt. The patient also reports to have narrowing of the veins, swelling and pain. The indication for the filter implant was dvt and an impending duodenal switch procedure for morbid obesity, for which anti-coagulation was contraindicated. The filter was implanted via the right common femoral vein and deployed in the infrarenal ivc without any reported complications and the patient tolerated the procedure well. There is currently no additional information available. The product was not returned for analysis. A review of the device history record (dhr) associated with lot 15042958 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 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 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 thrombosis within the filter do not represent a device malfunction. The timing and mechanism of the migration has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event. Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such. Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error. Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter. Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters. Without procedural films and post implant imaging available for review, the reported filter migration, clotting, blood clots, vena caval occlusion, ivc breakage and collapse could not be confirmed and the exact cause could not be determined. The instructions for use (ifu) states that migration is a potential complication associated with vena cava filters. With the limited information provided it is not possible to establish a relationship between the reported events and the device. Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency. With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in chronic edema of the affected extremity. Due to the nature of the complaint, the reported pain, veins narrowing and edema experienced by the patient could not be confirmed and the exact cause could not be determined. Pain, vein narrowing and edema do not represent a device malfunction and may be related to underlying patient specific issues. Given the limited information available for review, a relation between the device and the event(s) could not be determined. 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
As reported, the patient underwent placement of the optease filter. The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, ivc breakage, ivc migration, collapse of the inferior vena cava around the filter, the ivc filter being thrombosed, chronic dvt and subsequent clots leading to chronic edema. As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, and required extensive medical care and treatment including two ivc filter removal attempt. 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, 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 trapease 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. Occlusion within the filter, blood clots and chronic dvt do not represent a device malfunction. Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency leading to edema within lower extremities. Without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined. Giving the limited information available at this time, clinical factor contributing to the migration could not be determined. Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such. Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error. Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter. Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters. The brief also reported ¿ivc breakage¿ (perforation of the ivc); however, a clinical conclusion could not be determined as to the cause of the event. It is unknown if the migration contributed to the reported perforation. A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. The implantation date of the filter and 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, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in 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.
 
Event Description
As reported by the legal team, the patient underwent placement of the optease filter. The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, ivc breakage, ivc migration, collapse of the inferior vena cava around the filter, the ivc filter being thrombosed, chronic dvt and subsequent clots leading to chronic edema. As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, and required extensive medical care and treatment including two ivc filter removal attempt. As a direct and proxi_mate 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, 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, tipperary 33152
EI 33152
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6969666
MDR Text Key253311678
Report Number1016427-2017-00709
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
Report Date 03/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2012
Device Model Number466FXXXX
Device Catalogue Number466F220B
Device Lot Number15042958
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date09/28/2017
Event Location No Information
Date Manufacturer Received02/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2009
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: 10/23/2017 Patient Sequence Number: 1
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