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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F220A
Device Problems Failure to Align (2522); Migration (4003)
Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombus (2101)
Event Date 03/29/2019
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
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, tilting and large thrombus status post filter.
 
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 tilting and a large thrombus.The patient reported becoming aware of filter tilt, blood clots, clotting and/or occlusion of the inferior vena cava (ivc), approximately nine years post implant.The patient also reported experiencing anxiety related to the filter.The medical records provided, indicated that prior to the index procedure, the patient had been admitted from another facility after experiencing a 15-foot fall and suffering a subdural hematoma, subarachnoid hemorrhage and left posterior rib fracture.The medical history at the time included hypertension, coronary artery disease and hypothyroidism.During the hospitalization and shortly after admission, the patient was intubated, and an external ventricular drain was placed.Approximately eleven days later, the patient underwent a tracheostomy and percutaneous endoscopic gastrostomy (peg tube) insertion.Approximately seventeen days post admission, an optease vena cava filter was placed for the indication of left lower extremity deep vein thrombosis (dvt) in the presence of a subarachnoid hemorrhage and subdural hematoma.The filter was placed via the right femoral vein and deployed in the infrarenal ivc below the level of the renal veins at l2.There were no reported complications.The patient was discharged one month and a week after admission.The patient¿s medical history included hypertension, cardiovascular disease (cabg-double bypass and multiple stents), seven myocardial infarction implantable cardioverter- defibrillator implant, congestive heart failure with impella support, peripheral artery disease, resected portion of small intestines secondary to motor vehicle accident, hypothyroidism, and right knee surgery.A computed tomography (ct) scan of the abdomen was performed approximately ten years post implant.Results of the scan noted that the filter is tilted anteriorly 14 degrees.Approximately ten years and four months post implant, the patient presented to the emergency room with complaints of chest pain, that was relieved with 1 nitroglycerin pill.The patient was noted to be hypotensive and smelled strongly of alcohol.An echocardiogram noted a large apical thrombus left anterior descending artery infarct and a thrombus in the left ventricle.The patient was discharged five days later with a diagnosis of coronary artery disease, non-st elevate myocardial infarction, complicated with severe thrombocytopenia, most likely from alcohol toxicity.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 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/or occlusion of the inferior vena cava or the filter does not represent a device malfunction.Clinical factors that may have influenced the events include patient particularly of myocardial infarction and congestive heart failure, pharmacological and lesion characteristics.There is nothing in the reported information to suggest that there were blood clots or thrombus in the ivc or filter.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt could 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 tortuosity and technique.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the limited information provided 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.
 
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, tilting and large thrombus status post filter.Review of the medical records provided indicated that prior to the index procedure, the patient had been admitted from another facility after experiencing a 15-foot fall and suffering a subdural hematoma, subarachnoid hemorrhage and left posterior rib fracture.The medical history at the time included hypertension, coronary artery disease and hypothyroidism.During the hospitalization and shortly after admission, the patient was intubated, and an external ventricular drain was placed.Approximately eleven days later, the patient underwent a tracheostomy and percutaneous endoscopic gastrostomy (peg tube) insertion.Approximately seventeen days post admission, an optease vena cava filter was placed for the indication of left lower extremity deep vein thrombosis (dvt) in the presence of a subarachnoid hemorrhage and subdural hematoma.The filter was placed via the right femoral vein and deployed in the infrarenal inferior vena cava (ivc) below the level of the renal veins at l2.There were no reported complications.The patient was discharged one month and a week after admission.The patient¿s medical history included hypertension, cardiovascular disease (cabg-double bypass and multiple stents), seven myocardial infarction implantable cardioverter- defibrillator implant, congestive heart failure with impella support, peripheral artery disease, resected portion of small intestines secondary to motor vehicle accident, hypothyroidism, and right knee surgery.A computed tomography (ct) scan of the abdomen was performed approximately ten years post implant.Results of the scan noted that the filter is tilted anteriorly 14 degrees.Approximately ten years and four months post implant, the patient presented to the emergency room with complaints of chest pain, that was relieved with 1 nitroglycerin pill.The patient was noted to be hypotensive and smelled strongly of alcohol.An echocardiogram noted a large apical thrombus left anterior descending artery infarct and a thrombus in the left ventricle.The patient was discharged five days later with a diagnosis of coronary artery disease, non-st elevate myocardial infarction, complicated with severe thrombocytopenia, most likely from alcohol toxicity.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately nine years post implantation.The patient reports tilting of the filter, blood clots, clotting and or occlusion of the inferior vena cava (ivc).The patient further experienced anxiety related to the filter.
 
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Brand Name
OPTEASE RETRIEVAL FILTER
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
MDR Report Key9897331
MDR Text Key188510096
Report Number1016427-2020-03970
Device Sequence Number1
Product Code DTK
UDI-Device Identifier20705032009413
UDI-Public20705032009413
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 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2012
Device Model Number466F220A
Device Catalogue Number466F220A
Device Lot Number15089863
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK BENTSON WIRE; UNK BOSTON SCIENTIFIC J CURVED WIRE
Patient Outcome(s) Life Threatening;
Patient Age54 YR
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