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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
Model Number 466FXXXX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Atrial Fibrillation (1729); Exsanguination (1841)
Event Date 09/19/2017
Event Type  Injury  
Manufacturer Narrative
Outcomes attributed to adverse event. Implant date has been updated. No additional information will be forthcoming.
 
Manufacturer Narrative
Additional information received per the medical records indicate that the patient had a history of lower extremity deep vein thrombosis and recurrent pulmonary emboli. Four months prior to the index procedure, the patient had foot surgery. The filter was implanted immediately prior to a planned total left knee replacement procedure. The patient tolerated the index procedure well. The certificate of death listed the case of death as pulseless electrical activity (pea) arrest, metabolic acidosis and gastrointestinal bleeding. Contributing factors were listed as hypertension, hyperlipidemia, diabetes mellites type 2 and atrial fibrillation. Additional information received per the patient profile form (ppf) states that the patient experienced pulseless electrical activity (pea) arrest and gastrointestinal bleeding. Additional information is pending and will be submitted within 30 days of receipt.
 
Manufacturer Narrative
As reported, the patient underwent a surgical procedure to implant the optease¿ filter for the treatment and prevention of pulmonary emboli. The filter was implanted in the right common femoral vein. The device in the patient was positively identified on medical records. Approximately seven (7) years after the procedure, the patient was diagnosed with gastrointestinal bleed and atrial fibrillation. The patient at the time complained of abdominal pains in the region where his filter was implanted. On or about the same day, the patient passed away as a result of blood loss from his injuries. As the result of the patient's defective optease¿ filter, the optease suffered serious and possibly life-threatening and permanent injuries until the time of his death. The patient has suffered significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses before his untimely passing. 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 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. Gastrointestinal (gi) bleeding is when bleeding occurs in any part of the gastrointestinal tract. A gi bleed itself is not a disease, but a symptom of a number of many conditions. The untimely death of the patient, is an unfortunate result of the increased loss of blood. The experienced abdominal pain by the patient could possibly be contributed to the reported gi bleed. Atrial fibrillation is an abnormal heart rhythm. These reported events do not represent a device malfunction. Without medical records available for review, it is not possible to draw a clinical conclusion or determine a root cause for the reported events. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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 by legal team, the patient underwent a surgical procedure to implant the optease¿ filter for the treatment and prevention of pulmonary emboli. The filter was implanted in the right common femoral vein. The device in the patient was positively identified on medical records. Approximately seven (7) years after the procedure, the patient was diagnosed with gastrointestinal bleed and atrial fibrillation. The patient at the time complained of abdominal pains in the region where his filter was implanted. On or about the same day, the patient passed away as a result of blood loss from his injuries. As the result of the patient's defective optease¿ filter, the optease suffered serious and possibly life-threatening and permanent injuries until the time of his death. The patient has suffered significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses before his untimely passing.
 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6951130
MDR Text Key112323999
Report Number1016427-2017-00692
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 health professional,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date09/21/2017
Event Location No Information
Date Manufacturer Received01/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/16/2017 Patient Sequence Number: 1
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