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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
Catalog Number 466F220A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolus (1830); Occlusion (1984); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)
Event Date 06/20/2019
Event Type  Injury  
Manufacturer Narrative

As reported, the 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, damage to the patient, including but not limited to blood clots, caval stenosis and caval thrombosis. 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. Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction. A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive). Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli. Permanent ivc filters have been reported to obstruct in up to 20% of patients. 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 device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.   if obtained, a follow up report will be submitted within 30 days upon receipt.

 
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, damage to the patient, including but not limited to blood clots, caval stenosis and caval thrombosis. 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.

 
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Brand NameOPTEASE RETRIEVAL 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 Key10440471
MDR Text Key204001809
Report Number1016427-2020-04304
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466F220A
Device LOT NumberR0906250
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 Received01/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/19/2006
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: 08/22/2020 Patient Sequence Number: 1
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