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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 466P306X
Device Problem Unintended Movement (3026)
Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 03/04/2021
Event Type  Injury  
Manufacturer Narrative
Occupation: other, senior counsel, litigation. 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 stenosis, caval thrombosis and tilt. The patient reported becoming aware of filter tilt and stenosis approximately thirteen years and eleven months post implant. The patient also reported anxiety and occlusions. According to the medical records the indication for the filter implant was pulmonary embolism and deep vein thrombosis involving the right popliteal, posterior tibial and peroneal veins. The patient's right pulmonary artery pressure was measured, and the reading indicated that transcatheter thrombolysis was not necessary. The inferior vena cava was measured, and the filter was then positioned and deployed in a good position below the renal veins. There were no immediate complications. The product was not returned for analysis. A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. The trapease ivc 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. Blood clots, clotting, stenosis and occlusion of the device or the vasculature do not represent a device malfunction. Rather, patient and pharmacological factors may have contributed to these events. Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity. The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event. Without procedural films or post implant imaging available for review, the reported tilt and stenosis could not be confirmed or further clarified. Anxiety does not represent a device malfunction and may be related to underlying patient specific issues. There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken. Should additional information become available, the file will be updated accordingly.
 
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 stenosis, caval thrombosis and tilt. 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. Additional information received per the medical records indicate that the patient has a history of pulmonary embolism, bilateral leg swelling and pain. The patient had deep vein thrombosis involving the right popliteal, posterior tibial and peroneal veins. The patient's right pulmonary artery pressure was measured. Transcatheter thrombolysis was not necessary. The inferior vena cava was measured and the filter was then positioned and deployed in a good position below the renal veins. There were no immediate complications.   additional information received per the patient profile form (ppf) states that the patient experienced filter tilt and stenosis. The patient became aware of the reported events approximately thirteen years and eleven months after the index procedure. The patient also experienced psychological issues (anguish, anxiety, stress, worry) and occlusions.
 
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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 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key12264582
MDR Text Key264972929
Report Number1016427-2021-05225
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
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? Yes
Device Operator
Device Catalogue Number466P306X
Device Lot NumberR1206120
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
Date Device Manufactured12/15/2006
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: 08/02/2021 Patient Sequence Number: 1
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