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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CASHEL UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problem Defective Device (2588)
Patient Problems Coagulation Disorder (1779); Occlusion (1984)
Event Date 06/12/2019
Event Type  Injury  
Manufacturer Narrative
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 occlusion of the inferior vena cava (ivc).The indication for the filter implant, patient medical history and procedural details have not been provided.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 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 of the filter 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.With the limited information provided it is not possible to draw a conclusion between the events and the device.There is nothing in the information provided to suggest that there is 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.
 
Event Description
As reported by the legal department, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to occlusion of the inferior vena cava (ivc).
 
Event Description
As reported by the legal department, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to occlusion of the inferior vena cava (ivc).The following additional information was received per medical records: the patient presented with left dvt, bilateral pe and sob.The right common femoral vein was accessed under fluoroscopy and a venogrm was taken to locate renal veins.The ivc filter was successfully deployed below the l1 level without complication and the patient tolerated the procedure well.The following additional information was received per patient profile form (ppf): the patient became aware of the reported events approximately 12 years post implantation.The patient reports blood clots, clotting and occlusion of the ivc.The patient also reports suffering from anxiety.
 
Manufacturer Narrative
Additional information: section h6 (evaluation codes: addition of patient code 1779 and conclusion code 4310).Complaint conclusion: previous code of occlusion, new code of clotting and anxiety.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 occlusion of the inferior vena cava (ivc).The patient reported becoming aware of blood clots, clotting, and/or occlusion of the ivc approximately twelve years post implant.The patient also reported experiencing anxiety.According to the medical records the indication for the filter implant was a history of left lower extremity deep vein thrombosis and the development of bilateral pulmonary emboli despite adequate anticoagulation on coumadin.The filter was placed via the right common femoral vein and deployed just below the level of l1, below the level of the renal veins.The patient tolerated the procedure well.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 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 of the filter 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.With the limited information provided it is not possible to draw a conclusion between the events and the device.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the information provided to suggest that there is 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
UNKNOWN TRAPEASE
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
MDR Report Key9719849
MDR Text Key188358831
Report Number1016427-2020-03833
Device Sequence Number1
Product Code DTK
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 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number466P306X
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/04/2020
Initial Date FDA Received02/18/2020
Supplement Dates Manufacturer Received05/08/2020
Supplement Dates FDA Received05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age47 YR
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