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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466P306AU
Device Problems Difficult to Remove (1528); Unintended Movement (3026)
Patient Problems Embolus (1830); Occlusion (1984); Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)
Event Date 10/02/2013
Event Type  Injury  
Manufacturer Narrative
Occupation: other, senior counsel, litigation. Please note that the exact event date is unknown and the event date is the complaint awareness date. Please note that this is the initial report for this product. Additional information is pending and will be submitted within 30 days of receipt.
 
Event Description
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to embedment of filter and a failed removal attempt (three years and seven months after the index procedure). 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, and pain and suffering, and other damages. Information received per the patient profile form (ppf) states that the patient experienced embedment of filter and a failed removal attempt. The patient also experienced blood clots, clotting, and/or occlusion of the inferior vena cava (ivc). The patient became aware of the reported events three years and seven months after the index procedure. The patient continues to experience fear.
 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9913632
MDR Text Key188514683
Report Number1016427-2020-03980
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2012
Device Catalogue Number466P306AU
Device Lot Number15075387
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 Received10/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2020 Patient Sequence Number: 1
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