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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 11/27/2019
Event Type  Injury  
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 perforation and two ventral side struts that efface the pancreas uncinate process. 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, pain and suffering, and other damages.
 
Manufacturer Narrative
Occupation: other, senior counsel, litigation. Please note that the exact event date is unknown and the event date in date of event is the complaint awareness date. It was reported that a patient underwent placement of a trapease vena cava filter. The information provided indicated that the filter subsequently malfunctioned and caused inferior vena cava perforation. 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 events 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 perforation of the vena cava wall. ¿ additionally, the ifu notes vessel damage such as intimal tears 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 for review does not suggest that the reported event is related to 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. Please note that this is the initial report for this product.
 
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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 Key12700981
MDR Text Key281271948
Report Number9616099-2021-05009
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2008
Device Catalogue Number466P306AU
Device Lot NumberR1105653
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2005
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/26/2021 Patient Sequence Number: 1
Treatment
UNK COBRA CATHETER; UNK COBRA CATHETER; UNK MICRO SHEATH, UNK 0.35 J-GUIDEWIRE; UNK MICRO SHEATH, UNK 0.35 J-GUIDEWIRE; UNK NEEDLE, UNK MICRO WIRE; UNK NEEDLE, UNK MICRO WIRE
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