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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
Model Number 466P306AU
Device Problems Fracture (1260); Unintended Movement (3026)
Patient Problems Coagulation Disorder (1779); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 12/14/2020
Event Type  Injury  
Manufacturer Narrative
Reporter occupation: other, senior counsel, litigation. (b)(4). Additional information is pending and will be submitted within 30 days of receipt. Please note that this is the initial report for this product.
 
Event Description
As reported by the legal department, the patient underwent placement of the trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture, tilt, clot in filter, 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. Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt). The filter was deployed via the patient's right common femoral vein using ultrasound guidance. The filter was placed below the level of the renal veins and above the level of the bifurcation of the inferior vena cava into the common iliac veins. The patient tolerated the procedure well with no immediate complications. Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture within the inferior vena cava, tilt, blood clots, clotting and/or occlusion of the inferior vena cava (ivc). The patient became aware of the reported events sixteen years after the index procedure. The patient also experienced worry and was mentally disturbed.
 
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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 Key12277253
MDR Text Key265061564
Report Number1016427-2021-05240
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
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2007
Device Model Number466P306AU
Device Catalogue Number466P306AU
Device Lot NumberR0804389
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 Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2004
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: 08/04/2021 Patient Sequence Number: 1
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