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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problem Failure to Align (2522)
Patient Problems Coagulation Disorder (1779); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263); Blood Loss (2597)
Event Date 06/24/2017
Event Type  Injury  
Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter. The indication for the filter placement was not reported. At some point after the filter implantation, the patient became aware that the filter had tilted and was associated with perforation of all filter struts outside the wall of the inferior vena cava (ivc) with multiple struts perforating surrounding tissue and/or organs. 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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported filter tilt and perforation events could not be confirmed and the exact cause could not be determined. Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness. Additionally, the timing and mechanism of the filter tilt is unknown. It is unknown if the tilt contributed to the reported ivc and organ perforations. A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters. 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 the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics. Given the limited information available for review, there is nothing to suggest that a malfunction in 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 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, tilting and perforation of all filter struts outside the wall of the inferior vena cava (ivc) with multiple struts perforating surrounding tissue/organs. As a direct and proximate result of these malfunctions, 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 continue to suffer significant medical expenses, pain and suffering and other damages.

 
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Brand Name466FXXXX
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 Key9637592
MDR Text Key176755202
Report Number1016427-2020-03763
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466FXXXX
Device Catalogue Number466FXXXX
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 Received01/28/2020
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: 01/28/2020 Patient Sequence Number: 1
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