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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
Catalog Number 466FXXXX
Device Problem Device Inoperable (1663)
Patient Problems Pain (1994); Injury (2348)
Event Date 12/31/2017
Event Type  Injury  
Manufacturer Narrative

Please note that the event date is unknown and that the event date is the complaint awareness date. As reported, the patient had an optease inferior vena cava (ivc) implanted. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter tilt and filter migration. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment, including multiple surgeries. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. No additional information is available. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. The inferior vena cava (ivc) 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. Without images or procedural films for review, the reported filter tilt and migration cannot be confirmed. The timing and mechanism of the reported filter tilt is unknown. 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 includes 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. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or 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 this is the initial/final report for this file.

 
Event Description

As reported through the legal department via a legal brief, the patient had an optease inferior vena cava (ivc) implanted. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter tilt and filter migration. As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment, including multiple surgeries. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. No additional information is available.

 
Manufacturer Narrative

Additional information was received from the patient profile form which indicates the filter is unable to be retrieved, has migrated and is now tilted. The patient fears the filter may move causing more damage. She also has pain, shortness of breath and weakness. This has affected her ability to engage in daily activities as well as affected her mentally. Patient demographic information was received and section was updated accordingly. Additional information is pending and will be submitted within 30 days upon receipt.

 
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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
MDR Report Key7225055
MDR Text Key98466476
Report Number1016427-2018-01106
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNK
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 05/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466FXXXX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/31/2017
Event Location No Information
Date Manufacturer Received04/23/2018
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: 01/29/2018 Patient Sequence Number: 1
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