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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 466P306X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Date 09/09/2008
Event Type  Injury  
Manufacturer Narrative
As reported by the legal team, 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, caval thrombosis and will require life-long mediation to control anticoagulation.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, and pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.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 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.Caval thrombosis does not represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.However, given the limited information available for review at this time, there is nothing to 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.
 
Event Description
As reported by the legal team, 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, caval thrombosis and will require life-long mediation to control anticoagulation.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, and pain and suffering, and other damages.
 
Manufacturer Narrative
The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter due to having a history of severe deep vein thrombosis (dvt) with multiple pulmonary emboli (pe) even on coumadin.During placement of the ivc filter via right common femoral vein, the filter was deployed just below the renal veins.The patient tolerated the procedure well without any difficulty.According to the information received in the patient profile from (ppf), approximately one year and eight months post implantation of the ivc filter, the patient suffered a painful caval thrombosis requiring a thrombolysis procedure and now is on lifelong anticoagulation.Additionally, the patient has an occluded vena cava which has limited the patient¿s aerobic capacity causing the patient to get winded very easily and making walking stairs and hills a challenge.The patient also reports to suffer from general pain and mental anguish.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 injury and damages to the patient, including, but not limited to, caval thrombosis and will require life-long mediation to control anticoagulation.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, and pain and suffering, and other damages.According to the information received in the patient profile from (ppf), approximately one year and eight months post implantation of the ivc filter, the patient experienced a painful caval thrombosis requiring a thrombolysis procedure and now is on lifelong anticoagulation, the procedural details of that intervention have not been provided.The patient is also reported to have an occluded vena cava which has limited the patient¿s aerobic capacity causing the patient to get winded very easily and making walking stairs and hills a challenge.The patient also reports to suffer from general pain and mental anguish.The indication for the filter implant was a history of severe deep vein thrombosis (dvt) with multiple pulmonary emboli (pe), occurring twice, even though on coumadin.During placement of the ivc filter via right common femoral vein, the filter was deployed just below the renal veins.The patient tolerated the procedure well without any difficulty.There is currently no additional information available for review.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 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.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed, nor is it possible to establish a relationship between the reported events and the device.Anxiety, pain and shortness of breath do not represent a device malfunction and may be related to underlying patient specific issues and medical history.With the limited information available for review it is not possible to determine a relationship between the device and the reported events.Given the limited information currently available for review, there is nothing to suggest that a malfunction in 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.
 
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Brand Name
TRAPEASE PVCF FEM/JUG 55CM CSI
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 00000
EI  00000
MDR Report Key7385297
MDR Text Key103951142
Report Number1016427-2018-01327
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K020316
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number466P306X
Device Catalogue Number466P306AU
Device Lot NumberR1106318
Was Device Available for Evaluation? No
Distributor Facility Aware Date03/02/2018
Date Manufacturer Received04/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Disability;
Patient Age72 YR
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