MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306AU

Device Problem Failure to Align (2522)

Patient Problems Distress (2329); Injury (2348)

Event Date 02/07/2020

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 tilting of the filter.The indication for the filter implant has not been provided and 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Without imaging available for review the event could not be confirmed nor a cause attributed.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 in the legal brief, 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, physical and emotional damages from tilting of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.

Manufacturer Narrative

As reported, a patient had placement of a trapease inferior vena cava (ivc) filter.Per the implant records, the indication was pulmonary embolism (pe) and gastrointestinal (gi) bleeding.A venacavogram confirmed a patent ivc and single bilateral renal vein inflow at approximately the l1 level.Trapease type ivc filter was placed just inferior to the renal vein inflow.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, physical and emotional damages from tilting of the filter and the resultant symptoms.Per the patient profile form (ppf), the patient reports tilting of the filter, open wound on the lower left leg and issues with blood flow.The patient further reports anxiety.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 procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Open wounds, venous insufficiency and anxiety do not represent a device malfunction and may be related to underlying patient related issues.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 in the legal brief, 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, physical and emotional damages from tilting of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.Per the implant records, the filter was indicated for pulmonary embolism (pe) and gastrointestinal (gi) bleeding.Using real-time ultrasound guidance, a micro puncture needle was advanced into the right common femoral vein.This was exchanged over a guidewire for a trapease filter sheath.Digital subtraction angiography was used for the inferior vena cava (ivc) inferior venacavogram which confirmed a patent ivc and single bilateral renal vein inflow at approximately the l1 level.Trapease type ivc filter was placed in excellent location just inferior to the renal vein inflow and the repeat inferior venacavogram confirmed a patent ivc and excellent positioning of the inferior vena cava filter.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years and two months after the filter implantation.The patient reports tilting of the filter, and further experienced an open wound on the lower left leg that would not heal; issues with blood flow in the right leg where the blood gathers in pools and leaks through the skin; as well as stress and anxiety related to the filter.

Manufacturer Narrative

As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes deep venous thrombosis (dvt) and pulmonary embolism (pe) on chronic anticoagulation, tobacco abuse, hypertension, hyperlipidemia and syncope.The admission was complicated with acute hemorrhage, anemia and hypovolemic shock treated with blood transfusions.Digital subtraction angiography was used for the ivc venacavogram which confirmed a patent ivc and single bilateral renal vein inflow at approximately the l1 level.Trapease type ivc filter was placed in excellent location just inferior to the renal vein inflow and the repeat inferior venacavogram confirmed a patent ivc and excellent positioning of the inferior vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, physical and emotional damages from tilting of the filter and the resultant symptoms.Per the patient profile form (ppf), the patient reports tilting of the filter, and further experienced an open wound on the lower left leg that would not heal; issues with blood flow in the right leg where the blood gathers in pools and leaks through the skin; as well as stress and anxiety related to the filter.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 procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Open wounds, venous insufficiency and anxiety do not represent a device malfunction and may be related to underlying patient related issues.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 in the legal brief, 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, physical and emotional damages from tilting of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.Per the medical records, prior to the index procedure, the patient was admitted with a history of deep venous thrombosis (dvt) and pulmonary embolism (pe) on chronic anticoagulation.The admission was complicated with acute hemorrhage, anemia and hypovolemic shock treated with blood transfusions.A consultation with interventional radiology was ordered for placement of an ivc filter.The patient medical history at the time included tobacco abuse, hypertension, hyperlipidemia and history of syncope with extensive prior workup.Per the implant records, the filter was indicated for pe and gastrointestinal (gi) bleeding.Using real-time ultrasound guidance, a micro puncture needle was advanced into the right common femoral vein.This was exchanged over a guidewire for a trapease filter sheath.Digital subtraction angiography was used for the inferior vena cava (ivc) inferior venacavogram which confirmed a patent ivc and single bilateral renal vein inflow at approximately the l1 level.The trapease type ivc filter was placed in excellent location just inferior to the renal vein inflow and the repeat inferior venacavogram confirmed a patent ivc and excellent positioning of the inferior vena cava filter.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately seven years and two months after the filter implantation.The patient reports tilting of the filter, and further experienced an open wound on the lower left leg that would not heal; issues with blood flow in the right leg where the blood gathers in pools and leaks through the skin; as well as stress and anxiety related to the filter.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 10084765
• MDR Text Key: 192466782
• Report Number: 1016427-2020-03994
• Device Sequence Number: 1
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2020

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 Expiration Date: 07/31/2015
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15673551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/24/2020
• Supplement Dates Manufacturer Received: 07/07/2020; 07/30/2020
• Supplement Dates FDA Received: 07/15/2020; 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 0.018 GUIDEWIRE.; UNK 21G MICRO PUNCTURE NEEDLE.; UNK.
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR