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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 07/16/2020
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. 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 several struts of the filter to perforate the wall of the inferior vena cava (ivc) and the resultant symptoms. The indication for the filter implant, procedural details and medical history of the patient have not been provided and there is currently no additional information available for review. 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. Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu). The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters. Without images available for review the reported event could not be confirmed or further clarified. 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 the legal brief, a patient was treated with an unknown optease vena cava filter, which subsequently malfunctioned and caused injury and damage, including, but not limited to physical and emotional damages from several struts of the filter perforating the wall of the ivc and the resultant symptoms. 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 Key12106780
MDR Text Key259636444
Report Number1016427-2021-05047
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034050
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 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number466FXXXX
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 Received08/24/2021
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: 07/02/2021 Patient Sequence Number: 1
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