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

Model Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis (dvt), inferior vena cava (ivc) thrombosis, and unable to remove filter.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 device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior 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 procedural films available for review, it is not possible to clarify the location (proximal or distal) of the ivc thrombosis to the placement of the ivc filter.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf) and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological, lesion characteristics or other comorbidities.The presence of these clots do not represent a device malfunction.There is no medical evidence of a causal relationship between the vena cava filter and the formation of new dvt and thrombosis.There is no information in the briefing regarding a retrieval attempt made so a clinical cause to explain inability to remove filter is not possible with the limited information.However, the cordis trapease® permanent vena cava filter is designed as a permanent vena cava filter.Six straight struts that contain proximal and distal hooks are designed for fixation of the trapease filter to the vessel wall.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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, 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, deep vein thrombosis (dvt), ivc thrombosis, and unable to remove filter.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

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, deep vein thrombosis (dvt), blood clots, clotting and or occlusion of the inferior vena cava (ivc), and unable to remove the filter.There has been no documented attempt to remove the filter provided.The indication for the filter implant was pulmonary embolism with moderate respiratory distress and residual clot in the right popliteal veins.The filter was placed via the left femoral vein deployed above the bifurcation.A venacavogram was performed prior to placement and showed a patient left femoral vein and ivc and the renal veins were not well visualized.The patient tolerated the procedure well and was returned to the intensive care unit.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 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.The reported retrieval difficulty could not be confirmed or further clarified at this time.The reported event notes implantation of the filter on or about december 2005; however, the attempted retrieval date or an actual attempt at retrieval, is unknown at this time.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.With the limited information provided it is not possible to establish a relationship between the reported events and the device.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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, b5, b7, d1, g1, g3, g4, g7, h1, h2, h3 and h6.Section h6: patient code '1984' was used for occlusion of the inferior vena cava (ivc) and occlusion of the filter.As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.Patient history includes dvt (deep vein thrombosis) and pulmonary emboli.An inferior venocavagram revealed the ivc patent without clots.The filter was placed without difficulty.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, dvt, ivc thrombosis, and unable to remove filter.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved.There is no documentation of a retrieval attempt.Occlusion of the filter caused the patient to need placement of an additional ivc filter.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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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

According to the information received in the patient profile form (ppf), the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved.There is no documentation of a retrieval attempt.The patient became aware of the alleged failures two years and two months post implantation.The ppf also states that the patient was diagnosed with deep vein thrombosis (dvt) four years before implantation.The following additional information received per the medical records state that the patient has a history of pulmonary emboli and moderate respiratory distress.During the implant procedure, access to the left femoral vein was obtained percutaneously with a micropuncture stick and then a sonosite was used to guide this area.The patient then had placement of an inferior vena cavagram to this area that revealed the left femoral vein patent and ivc patent without clots.The renal veins were not well seen but could be extrapolated where they could potentially be.The patient then had the ivc filter placed without difficulty.The introducers were removed and pressure held, and there was no further bleeding.The patient tolerated the procedure well.Additional to the previously reported events, a legal short form was received which states that the patient also experienced occlusion of the inferior vena cava (ivc) filter.Occlusion of the filter caused the patient to need placement of an additional ivc filter.

• 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: 7671531
• MDR Text Key: 113501899
• Report Number: 1016427-2018-01629
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN INTRODUCER
• Patient Outcome(s): Life Threatening
• Patient Age: 83 YR