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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 466F220A
Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Ulcer (2274)
Event Date 04/01/2016
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, left lower edema with stasis ulcers related to ivc filter placement.The patient suffered life-threatening injuries and damages, requiring 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.
 
Event Description
As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, left lower edema with stasis ulcers related to ivc filter placement.The patient suffered life-threatening injuries and damages, requiring 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.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 8 years and 7 months post implantation.The patient reports tilt.The patient also reports suffering from anxiety.
 
Manufacturer Narrative
The implant date was confirmed to be accurate.The exact event date is unknown.Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
Complaint conclusion: as reported, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, left lower edema with stasis ulcers related to the inferior vena cava (ivc) filter placement.The patient suffered life-threatening injuries and damages, requiring 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.The inferior 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.Without medical records available for review a clinical relationship between the events reported and their relation to the placement of the device is unable to be determined at this 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, leading to lower extremity edema.The skin of the lower legs can become thick, dry, and fragile.This may lead to ulceration of the skin - usually on the inside aspect of the leg just above the ankle.The brief does not mention a malfunction of the filter.Given the limited information available for review, a relation between the device and the event could not be determined.Pain does not represent a device malfunction.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
Section b5: the following additional information received per the medical records indicate that the patient had a pre-operative diagnosis of cervical fracture and bed fast.The patient tolerated the procedure well.It was reported that 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, left lower edema with stasis ulcers related to ivc filter placement.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately 8 years and 7 months post implant.The patient reports that the filter has tilted and is experiencing swelling, pain, and anxiety.The medical records indicated that the patient had a diagnosis of cervical fracture and was ¿bed fast¿, prior to placement.The filter was placed in addition to a percutaneous intravenous central catheter and was reported to have tolerated the procedure well.There is currently no additional information available for review.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 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.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.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 swelling of the affected extremity.Venous stasis ulcers develop as a result of blood pooling in the lower extremities from weak valves, blocked and or scarred veins.Pain, swelling and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with vessel characteristics, specifically asymmetry and tortuousity and technique.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.Should additional information become available, the file will be updated accordingly.
 
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Brand Name
OPTEASE RETRIEVAL FILTER
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
MDR Report Key7636303
MDR Text Key112276314
Report Number1016427-2018-01573
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number466F220A
Device Catalogue Number466F220A
Device Lot NumberR0407458
Was Device Available for Evaluation? No
Date Manufacturer Received12/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age44 YR
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