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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL UNKNOWN OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466FXXXX
Device Problem Migration (4003)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Thrombosis (2100)
Event Date 12/15/2006
Event Type  Injury  
Manufacturer Narrative
Occupation: other, senior counsel, litigation. Description of problem or event: as reported, the patient had placement of an optease inferior vena cava (ivc) filter. Per the medical records, history includes trauma, a motor vehicle accident, and right kidney and right renal vein are absent. The records also noted that the patient has a double inferior vena cava. The patient had placement of two optease vena cava filters. Both filters were deployed via the patient's right internal jugular vein. An ultrasound was used to identify the double inferior vena cava (ivc). A filter was deployed into the left-sided ivc first. The second filter was deployed anterior to the right-sided ivc. There were no complications. The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to migration, deep vein thrombosis (dvt), and the filter is embedded and unable to be retrieved. Per the patient profile form (ppf), the patient reports migration of entire filter other than to heart, filter embedded in wall of the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc and device unable to be retrieved. The ppf also states that thrombus and deep vein thrombosis (dvt) were discovered in doppler ultrasound performed. It was noted that the patient's filter migrated to the left common iliac vein at a later examination. Due to embedment and other previous complications, the doctors advised the patient that the filter was unable to be retrieved. There have been no documented attempts to remove either device. The patient continues to experience emotional distress, mental anguish, anxiety and stress. 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. 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 include 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 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. Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. 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. Please note that this is the initial/final report for this product.
 
Event Description
As reported by the legal brief, the 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: migration, deep vein thrombosis (dvt), and the filter is embedded and unable to be retrieved. 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. Additional information received per the medical records indicate that the patient has a history of trauma, a motor vehicle accident and the patient's right kidney and right renal vein are absent. The records also noted that the patient has double inferior vena cavas. The patient underwent placement of two optease vena cava filters. Both filters were deployed via the patient's right internal jugular vein. An ultrasound was used to identify the double inferior vena cava (ivc). A filter was deployed into the left-sided ivc first. The second filter was deployed anterior to the right-sided ivc. There were no complications. Additional information received per the patient profile form (ppf) states that the patient experienced migration of entire filter other than to heart, filter embedded in wall of the inferior vena cava (ivc), blood clots, clotting, and/or occlusion of the ivc and device unable to be retrieved. The patient became aware of the reported events one week after the index procedure. The ppf also states that thrombus and deep vein thrombosis (dvt) were discovered in doppler ultrasound performed. It was noted that the patient's filter migrated to the left common iliac vein at a later examination. Due to embedment and other previous complications, the doctors advised the patient that the filter was unable to be retrieved. There have been no documented attempts to remove either device. The patient continues to experience emotional distress, mental anguish, anxiety and stress.
 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8596437
MDR Text Key144592832
Report Number1016427-2019-02793
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/09/2019 Patient Sequence Number: 1
Treatment
UNKNOWN SHEATH
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