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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problem Occlusion Within Device (1423)
Patient Problems Coagulation Disorder (1779); Dyspnea (1816); Occlusion (1984); Thrombosis (2100)
Event Date 11/01/2016
Event Type  Injury  
Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date. As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: blood clots in the filter and caval thrombosis. As a direct and proximate result, 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. No additional information is available. The device was not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. The trapease 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. A caval thrombosis and blood clots noted in the filter does not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events. 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 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 product.

 
Event Description

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter. The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: blood clots in the filter and caval thrombosis. As a direct and proximate result, 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. No additional information is available.

 
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Brand Name466P306X
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 Key7557950
MDR Text Key109702672
Report Number1016427-2018-01509
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466P306X
Device Catalogue Number466P306X
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/12/2018
Event Location No Information
Date Manufacturer Received09/03/2018
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: 05/31/2018 Patient Sequence Number: 1
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