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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Depression (2361)
Event Date 02/10/2016
Event Type  Injury  
Manufacturer Narrative
As reported, a 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 damage to the patient, including, but not limited to, failed removal and filter embedment.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the 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.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.
 
Event Description
As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, failed removal and filter embedment.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.
 
Event Description
As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, failed removal and filter embedment.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a preoperative diagnosis of multiple trauma with inability to anticoagulate due to liver and head trauma.Ultrasound guidance was used to assist puncture after prepping and draping the right groin and lidocaine administration.An arterial puncture was carried out on two occasions with a micro puncture, finally entering the vein to place a micro puncture sheath and a wire.The dilator and sheath for the optease filter were advanced and a cavogram obtained twice isolating the renal veins.The optease filter was then deployed about 2.5cm below the left renal vein.The patient tolerated the procedure.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately a month after the filter implantation.The patient reports filter embedded in wall of the ivc, device unable to be retrieved along with a failed percutaneous removal procedure attempted approximately one month after the filter was implanted.The patient further experienced fear, anxiety, loss of sleep related to the filter, which has resulted in depression for which the patient is currently being treated.
 
Manufacturer Narrative
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 filter embedment and failed removal.The patient reported becoming aware of embedded in wall of the inferior vena cava (ivc), and device unable to be retrieved approximately one-month post implant when a failed percutaneous removal procedure was attempted.The patient has also reported fear, anxiety and loss of sleep related to the filter resulting in depression for which the patient is currently being treated.According to the implant record the indication for the filter implant was a multiple trauma patient with liver and head injury and therefore unable to anticoagulate.The filter was placed via the right groin and deployed, after isolating the renal veins, about 2.5cm below the left renal vein.The patient tolerated the procedure.There is currently no additional information available for review.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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.Without procedural details an exact cause for the reported events could not be determined.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Anxiety and depression do not represent a device malfunction and may be related to underlying patient specific issues.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.
 
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Brand Name
466FXXXX
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014 2802
MDR Report Key10366971
MDR Text Key201682743
Report Number1016427-2020-04254
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 other
Type of Report Initial,Followup
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Date Manufacturer Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK MICRO PUNCTURE SHEATH; UNK WIRE
Patient Outcome(s) Life Threatening;
Patient Age20 YR
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