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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); Failure to Align (2522)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); Neuropathy (1983); Occlusion (1984); Swelling (2091); Thrombosis (2100); Thrombus (2101)
Event Date 08/20/2014
Event Type  Death  
Manufacturer Narrative
The following additional information received per the patient profile form (ppf) indicates that the filter was unable to be retrieved although there have been no documented attempts made to retrieve the filter. The patient also reports to suffer from leg swelling and pain. According to medical records, the patient had a history of deep vein thrombosis (dvt), intracranial hemorrhage, and was unable to anticoagulate. The filter was successfully deployed and the patient tolerated the procedure well. Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
After further review of additional information received the following have been updated accordingly. As reported, the patient had an optease retrievable inferior vena cava (ivc) filter implanted. The indication for filter implant was a history of deep vein thrombosis (dvt), intracranial hemorrhage, and was unable to anticoagulate. The filter was successfully deployed and the patient tolerated the procedure well. The filter subsequently malfunctioned and caused injury and damages to the patient including but not limited to, blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities. 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 following additional information received per the patient profile form (ppf) indicates that the filter was considered too dangerous to be removed, and there have been no documented attempts made to retrieve the filter. The patient also reports to suffer from leg swelling, pain and filter occlusion. The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor the device history record (dhr) 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 do not represent a device malfunction. The predominant concern for embedding with in the wall of the ivc is the development of endothelialization. Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells. This is the normal process whereby the body heals and recovers from invasive procedures. Endothelialization has been shown to occur in as short a period as 12 days. Swelling of the legs with resultant peripheral neuropathy and pain to dot represent device malfunctions. These events may be related to underlying patient specific issues. Clinical factors that may have influenced the event include patient co-morbidities, 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.
 
Manufacturer Narrative
It was reported that a patient had an optease retrievable inferior vena cava (ivc) filter implanted. 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 ivc filter, and resulting neuropathy in the lower extremities. The information provided also indicated that the filter was unable to be retrieved, there have been no documented attempts made to retrieve the filter. The information provided indicates that the filter was evaluated on two different occasions for removal, however, it is unclear if an actual removal procedure took place. The patient also reports to suffer from leg swelling, pain and filter occlusion. According to medical records, the patient had a history of deep vein thrombosis (dvt), intracranial hemorrhage, and was unable to be anticoagulated. The filter was implanted via the right internal jugular vein and placed with the cephalad cone of the filter immediately below the level of the renal veins, with the filter noted above the level of the venous confluence in good position. The patient is reported to have tolerated the procedure well. There is currently no additional information available for review. The product was not returned for analysis. The dhr could not be completed. 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 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, resulting in swelling/edema/bulging of the effected extremity(s). Blood clots and thrombosis within the filter do not represent a device malfunction. Occlusion of the ivc filter was reported, however the mechanism of the occlusion was not. Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics. Without the procedural films or post-placement imaging and the limited information provided, the report of blood clots, clotting and occlusion of the inferior vena cava (ivc) and filter could not be confirmed, nor can a conclusion about a relationship between the reported events and the filter be drawn. Pain and leg swelling do not represent do not represent a device malfunction and may be related to underlying patient specific issues. There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
 
Manufacturer Narrative
The product is not available for evaluation and testing.  as reported via the legal department, notification of legal action was received. The plaintiff underwent optease retrievable inferior vena cava (ivc) filter implantation which subsequently malfunctioned. The device, inter alia, caused blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities. 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 remains implanted in the patient and is not available for inspection. Manufacturing records (dhr) could not be reviewed, as the product catalog and lot number are not available. The purpose of a vena cava filter is to catch thrombus (a clot of blood formed within a blood vessel) from the lower extremities as it travels along normal blood flow patterns up towards the heart. Thrombus in the filter or within the vessel does not represent a device malfunction. Thrombosis in the filter is a well-known potential complication and occurs in approximately 3. 6 to 11. 2% of all patients. As such, it is addressed in the product¿s instructions for use (ifu). Factors that may contribute to thrombus may include patient factors, pharmacological and lesion characteristics. Peripheral neuropathy is damage to or disease affecting nerves, which may impair sensation, movement, gland or organ function, or other aspects of health, depending on the type of nerve affected. Common causes of peripheral neuropathy include systemic diseases (such as diabetes or leprosy), vitamin deficiency, medication, antibiotics, traumatic injury, radiation therapy, excessive alcohol consumption, immune system disease, coeliac disease, or viral infection. Based on the limited information available for review, there is no indication of a design or manufacturing related cause for these events. Therefore, no corrective action will be taken at this time. 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 (b)(6), the patient had an optease retrievable inferior vena cava (ivc) filter implanted. The filter subsequently malfunctioned and caused injury and damages to the plaintiff including: but not limited to, blood clots, clotting and occlusion of ivc filter, and resulting neuropathy in the lower extremities. 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, co. tipperary
miami FL
EI
MDR Report Key6120944
MDR Text Key120748560
Report Number1016427-2016-00124
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466F220A
Device Lot NumberR0404524
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date10/31/2016
Event Location No Information
Date Manufacturer Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/22/2016 Patient Sequence Number: 1
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