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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
Catalog Number 466FXXXX
Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522); Material Deformation (2976); Unintended Movement (3026)
Patient Problems Embolus (1830); Perforation of Vessels (2135)
Event Date 10/08/2018
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 and damage to the patient including, but not limited to tilt of the filter, perforation of the filter prongs through the ivc wall, malformation of the filter and fractured filter legs. The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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 instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. 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. Altered shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time. 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.
 
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 damage to the patient including, but not limited to tilt of the filter, perforation of the filter prongs through the inferior vena cava (ivc) wall, malformation of the filter and fractured filter legs.
 
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Brand NameUNKNOWN OPTEASE VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8365775
MDR Text Key136987182
Report Number1016427-2019-02545
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number466FXXXX
Device Lot NumberUNKNOWN
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 Received03/19/2019
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: 02/25/2019 Patient Sequence Number: 1
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