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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 Migration or Expulsion of Device (1395); Unintended Movement (3026)
Patient Problems Coagulation Disorder (1779); Emotional Changes (1831); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 02/18/2021
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported by the legal brief, a patient underwent placement of a trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to organ perforation, tilting, stenosis and caval thrombosis. 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 suffer significant medical expenses, pain and suffering and other damages. Per the implant records, the patient was reported to have a preoperative diagnosis of hypercoagulability with recurrent deep vein thrombosis (dvt) and poor compliance with coumadin administration. The patient¿s right groin was prepped and draped in a sterile fashion. The right femoral vein was cannulated using seldinger technique and a guidewire was passed without incident. Under fluoroscopy guidance, a vena cavography was performed and the area between l2-l3 was identified. The filter was then deployed starting at the mid body of l2 and extending inferiorly. The patient tolerated the procedure well.
 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014-2802
7863138372
MDR Report Key12239032
MDR Text Key264037862
Report Number1016427-2021-05147
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466P306AU
Device Catalogue Number466P306AU
Device Lot NumberR0907315
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 Received07/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1
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