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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 466P306X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Perforation of Vessels (2135)
Event Date 01/14/2019
Event Type  Injury  
Event Description
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter. The filter subsequently malfunctioned and caused injury and damages including, but not limited to: perforation.
 
Manufacturer Narrative
The exact implant date is unknown. The catalog number is unknown, if received it will be provided. Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter. The indication for the filter placement was not reported. At some point after the filter implantation, the patient became aware that the filter was associated with perforation. 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 trapease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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. Without images or procedural films for review, the reported perforation could not be confirmed and the exact cause could not be determined. A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters. Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation. Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics. Given the limited information available for review, there is nothing to suggest that a malfunction in 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.
 
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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 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12956957
MDR Text Key282321697
Report Number9616099-2021-05135
Device Sequence Number1
Product Code DTK
UDI-Device Identifier20705032009451
UDI-Public20705032009451
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,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2006
Device Model Number466P306X
Device Catalogue Number466P306AU
Device Lot NumberR0503844
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2003
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: 12/07/2021 Patient Sequence Number: 1
Treatment
UNK.
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