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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
Model Number 466FXXXX
Device Problems Filter (816); Failure to Align (2522); Migration (4003)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative

Complaint conclusion: 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 migration of inferior vena cava (ivc) filter located in the lower ivc with the inferior tip in the right iliac vein. The indication for the filter implant and medical/procedural records 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. The timing and mechanism of the migration has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event. 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. With the very limited information provided and without the procedural films or post implant images to review the reported events could not be further clarified. Given the limited information currently available for review, 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 by the legal brief, the patient underwent placement of an optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages including, but not limited to: the patient suffered physical and emotional damages from a migration of ivc filter located in the lower ivc with the inferior tip in the right iliac vein. As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and 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 60 avenue
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 Key10322373
MDR Text Key200426823
Report Number1016427-2020-04227
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
Type of Report Initial,Followup,Followup
Report Date 09/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466FXXXX
Device Catalogue Number466F220A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
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: 07/24/2020 Patient Sequence Number: 1
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