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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION UNKNOWN TRAPEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466P306X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 07/07/2021
Event Type  Injury  
Manufacturer Narrative
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, there is specific evidence that the filter perforates the inferior vena cava (ivc) wall. 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. The device was not returned for analysis. No lot number was provided therefore a product history record (phr) review could not be generated. The reported ¿inferior vena cava perforation¿ could not be confirmed as the device was not returned for analysis. The exact cause of the reported event could not be conclusively determined. Procedural/handling factors, or vessel characteristics, although unknown, may have contributed to the reported event. According to the ifu, which is not intended as a mitigation of risk, ¿possible long-term complications associated with filter implantation include, but are not limited to, the following: filter obstruction, filter perforation of the vena cava wall, filter migration, filter fracture, recurrent pulmonary embolism. ¿ additionally, the ifu notes vessel damage and perforation as procedural complications related to ivc filters. Without images available for review the reported perforation could not be confirmed or further clarified. Since no lot number was provided a phr could not be generated. The limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time. Should additional information become available, the file will be updated accordingly.
 
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, there is specific evidence that the filter perforates the ivc wall. 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.
 
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Brand NameUNKNOWN TRAPEASE
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 Key12259532
MDR Text Key264510310
Report Number1016427-2021-05203
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
Report Date 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/02/2021 Patient Sequence Number: 1
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