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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL FEMORAL 55CM KIT FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL FEMORAL 55CM KIT FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466FXXXX
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)
Event Date 11/06/2015
Event Type  Death  
Manufacturer Narrative

As reported, a 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, directly and proximately causing pulmonary embolism and death. The filter remains implanted; thus, unavailable for analysis. 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. Post procedure pulmonary embolism, resulting in death, is a known potential adverse event associated with the use of the ivc filters. These events may be related to excessive clot burden from underlying patient specific factors. 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. Should additional information become available, the file will be updated accordingly.

 
Event Description

As reported by the legal department, 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, directly and proximately causing pulmonary embolism and death. As a direct and proximate result of these malfunctions, the patient suffered fatal injuries, damages, and ultimately death.

 
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Brand NameFEMORAL 55CM KIT
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 Key8971514
MDR Text Key156819032
Report Number1016427-2019-03285
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 10/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2018
Device MODEL Number466FXXXX
Device Catalogue Number466F230AF
Device LOT Number17322278
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 Received09/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/30/2015
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: 09/06/2019 Patient Sequence Number: 1
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