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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CASHEL 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 Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Vascular System (Circulation), Impaired (2572)
Event Date 03/08/2018
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. As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter. The indication for filter placement is not available. The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to stenosis inferior to the filter, post-implant deep vein thrombosis and post-implant pulmonary embolism. The filter remains implanted; thus, unavailable for analysis. 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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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. Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction. A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive). Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli. Permanent ivc filters have been reported to obstruct in up to 20% of patients. Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction. Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events. Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics. 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 stenosis inferior to the filter, post-implant deep vein thrombosis and post-implant pulmonary embolism. 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, and pain and suffering, and other damages.
 
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Brand NameTRAPEASE PVCF FEM/JUG 55CM CSI
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8319879
MDR Text Key135506817
Report Number1016427-2019-02480
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,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number466P306AU
Device Lot NumberR0107038
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 Received06/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2007
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: 02/08/2019 Patient Sequence Number: 1
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