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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466P306X
Device Problems Difficult to Remove (1528); Defective Component (2292)
Patient Problems Pulmonary Embolism (1498); Thrombosis (2100)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
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 reoccurring deep vein thrombosis, pulmonary embolisms and the filter is unable to be retrieve.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.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.
 
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 reoccurring deep vein thrombosis, pulmonary embolisms and the filter is unable to be retrieve.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
Additional information: section a2 (age at the time of event, date of birth).Section b1 (adverse event and malfunction).Section b4 (event description).Section b7 (relevant medical history).Section g4 (date received by the manufacturer).Section h6 (evaluation codes- additional of device codes).Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of morbid obesity, asthma, smoking, deep vein thrombosis (dvt) and pulmonary embolus (pe).In addition, the patient had had a recent motor vehicle accident with a closed head trauma, chest trauma with recurrent pneumo/hemothoraces and tracheostomy, multiple fractures and extended bedrest.The patient¿s hospital course was further complicated by pneumonia, sepsis, fungemia, acute respiratory distress syndrome, acute renal failure and gastrointestinal bleeding (secondary to anticoagulation).The filter was implanted via the left common femoral vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well and without complications.At some point after the filter implantation, the patient reported having experienced recurring dvt and pe.In addition, the patient indicated that the filter could not be retrieved; though attempts to retrieve it were not documented.Approximately sixteen years after the implantation, the patient underwent a doppler study and a computerized tomography (ct) scan that revealed no evidence of dvt and no acute abdominal process.The filter was further noted to be in place with no clot or filling defected associated with it.A repeat ct scan done approximately one year later noted that the filter was in its¿ correct location and no complications associated with the device were noted.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 pe via percutaneous placement in the ivc 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.Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.The trapease vena cava filter is designed for permanent implantation.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as twelve days.Recurrent pe is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information 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.
 
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 reoccurring deep vein thrombosis, pulmonary embolisms and the filter is unable to be retrieve.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 following additional information was received per implant records: the indication for ivc filter was mva with closed head trauma, chest trauma with tracheotomy, multiple fractures, extended bedrest, and gi bleed secondary to anticoagulation.Medical history at that time included dvt and pulmonary embolus.Venogram was done to size the ivc and locate the renal veins.The filter was successfully deployed in an infra-renal position and there were no reported complications.The following additional information was received per medical records: a doppler study and ct scan performed approximately 16 years post ivc filter implantation revealed no evidence of dvt and no acute abdominal process, respectively.A ct scan performed approximately 1 year following revealed the ivc filter is in correct location and no complications were noted.
 
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Brand Name
466P306X
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
MDR Report Key9219172
MDR Text Key163638061
Report Number1016427-2019-03435
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 03/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number466P306X
Device Catalogue Number466P306X
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK.
Patient Outcome(s) Life Threatening;
Patient Age20 YR
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