MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001); Thrombosis (2100)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.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 damage to the patient including, but not limited to deep vein thrombosis, clot in filter, tilting of filter and filter strut perforation.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.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 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.Without images or procedural films for review, the reported filter tilt and perforation could not be confirmed, and the exact causes could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.With the limited information provided, it is not possible to determine what factors may have contributed to the reported deep vein thrombosis and thrombus within the device.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.The trapease vena cava filter is not indicated for use in the prevention of dvt.Without procedural films or images and the patient¿s medical history available for review the reported event(s) could not be confirmed and a clinical determination made.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 deep vein thrombosis, clot in filter, tilting of filter and filter strut perforation.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

Section b5: additional information received per the medical records indicate that the patient has a history of severe large bilateral pulmonary artery embolus, deep vein thrombosis and shock.The filter was deployed via the right femoral vein.The patient tolerated the procedure well.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside of the inferior vena cava, blood clots, clotting and or occlusion of the inferior vena cava.The patient became aware of the reported events approximately four years after the index procedure.The patient continues to experience mental anguish, fear, anxiety, pain in left side of groin/leg and sexual drive.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 damage to the patient including, but not limited to deep vein thrombosis, clot in filter, tilting of the filter and filter strut perforation.Additional information indicated that the patient experienced perforation of filter struts outside of the inferior vena cava, blood clots, clotting and or occlusion of the inferior vena cava.The patient became aware of the reported events approximately four years after the index procedure.The patient also reports to experience mental anguish, fear, anxiety, pain in left side of groin/leg and sexual drive.The indication for the filter implant was severe large bilateral pulmonary artery embolus, deep vein thrombosis and shock.The filter was placed via the right femoral vein and deployed under fluoroscopy without difficulty.The patient is reported to have tolerated the procedure well.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 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.Without images or procedural films for review, the reported filter tilt and perforation could not be confirmed, and the exact causes could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time.It is unknown if the tilt contributed to the reported perforation.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.The trapease vena cava filter is not indicated for use in the prevention of dvt.Anxiety, pain, and loss of sexual drive do not represent a device malfunction and may be related to underlying patient specific issues.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.Without procedural films or post implant images and the patient¿s medical history available for review the reported event(s) could not be confirmed and a clinical determination made.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.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8104220
• MDR Text Key: 128387397
• Report Number: 1016427-2018-02311
• Device Sequence Number: 0
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2018
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN GUIDE WIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 46 YR