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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Filter (816); Failure to Align (2522)
Patient Problem Perforation (2001)
Event Date 09/08/2017
Event Type  Injury  
Manufacturer Narrative

Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available. Patient age and medical history were also not provided. If obtained, a follow up report will be submitted within 30 days upon receipt. Please note that the contact is not a medical professional but a more accurate choice is not available. As reported, a patient was treated with an optease inferior vena cava (ivc) filter. The indication for filter placement is not available. The filter subsequently malfunctioned and caused injury, damage to the patient including, but not limited to physical and emotional damages from perforation and tilt of the filter. 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. Without procedural films for review, the filter tilt reported could not be confirmed. Additionally, the timing and mechanism of the filter tilt is unknown. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event. A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters. Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place. Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation. 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 a legal brief, a patient was treated with an optease vena cava filter, the filter subsequently malfunctioned and caused injury, damage, to the patient including, but not limited to physical and emotional damages from perforation and tilt of the filter. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.

 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10283521
MDR Text Key199120229
Report Number1016427-2020-04204
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number466F220A
Device LOT NumberR0708460
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/29/2008
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: 07/16/2020 Patient Sequence Number: 1
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