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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 Fracture (1260)
Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001); Perforation of Vessels (2135)
Event Date 12/07/2018
Event Type  Injury  
Manufacturer Narrative
Occupation: other, senior counsel, litigation. Please note that the exact event date is unknown and the event date 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 fracture, perforation, occlusion and perforation abutting an adjacent organ. The indication for the filter placement has not been provided and there is currently no additional information available for review. 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 vena cava 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. Occlusion was reported, however with the limited information provided the event could not be further clarified, it is unknown if it was a stenotic or thrombotic event. Blood clots, clotting and/or occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event. A review of the ifu notes vessel damage such as intimal tears and perforation as procedural and long-term complications related it ivc filters. Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place. Without procedural films or images for review the reported event(s) could not be confirmed. Given the limited information available for review at this time, there is nothing to suggest that the reported events are 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/final report for this product.
 
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 fracture, perforation, occlusion and perforation abutting an adjacent organ that causes injury.
 
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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 33152
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33152
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9905258
MDR Text Key188527109
Report Number1016427-2020-03975
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 05/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2005
Device Catalogue Number466P306AU
Device Lot NumberR1002563
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 Received05/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2002
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: 03/31/2020 Patient Sequence Number: 1
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