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

Model Number 466P306X

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Thromboembolism (2654); No Code Available (3191)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had tilted and had become embedded.The patient also reported having experienced caval thrombosis, thrombosis/embolism, post-thrombotic syndrome, leg swelling and pain.In addition, the patient indicated that the filter could not be retrieved; though attempts to retrieve it were not documented.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 inferior vena cava (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 images or procedural films for review, the reported filter tilt and device embedment events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.The trapease vena cava filter is designed for permanent implantation.Endothelialization has been shown to occur in as short a period as twelve days.Post-thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported leg swelling and pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events 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 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, tilting, filter is embedded and unable to be retrieved, caval thrombosis, thrombosis/embolism, post thrombotic syndrome, leg swelling and pain post implant.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, 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 tilting, filter is embedded and unable to be retrieved, caval thrombosis, thrombosis/embolism, post thrombotic syndrome, leg swelling and pain post implant.The patient reported becoming aware of the events approximately eight years and nine months post implant.The patient underwent an unsuccessful percutaneous removal attempt approximately eleven years and six months post implant.The patient indicated the events were reported from a computed tomography (ct) scan and the attempted removal of the filter.The patient has also reported leg swelling and pain post implant and anxiety related to the filter.According to the implant record the indication for the filter implant was extensive deep vein thrombosis (dvt) and failure of anticoagulation therapy.The filter was placed via the right common femoral vein and deployed below the entrance of the left renal vein in the inferior vena cava (ivc).The ivc was noted to be thrombus free at the time of the implant.The patient tolerated the procedure well.Approximately eleven years and six months post implant the patient underwent evaluation and attempted removal of the ivc filter.The patient was noted to have a complex prothrombotic history including protein c and protein s deficiency with recurrent venous thromboembolism.After having the ivc filter implanted the patient had subsequent venous hypertension within the bilateral lower extremities, manifested by leg swelling, recurrent dvt, pain and decreased mobility.Chronic total occlusion of the left iliac venous system with recent recanalization and stenting performed, improved the symptoms and mobility.The patient now returned for evaluation and management of caval disease.The patient underwent a technically challenging complex endovascular procedure with initial attempts to remove the permanent trapease filter which were eventually deferred due to inability to successfully centralize the inferior aspect of the filter within the laser sheath.The decision was then made to proceed with intravascular stenting.Overlapping wallstents were placed in the ivc through the filter to the suprarenal cava and subsequently balloon dilated, demonstrating extensive compression within the filter.Further angioplasty of the lesions within the right common iliac vein was performed, followed by argatroban anticoagulation.Completion venography demonstrated restoration of high velocity antegrade flow through the right common iliac venous system and diminished collaterals.The patient tolerated the procedure well.There were no immediate complications.The evaluation findings included a filter within the infrarenal cava with extensive chronic thrombotic and fibrotic material occluding the right aspect of the filter and surrounding the inferior and superior pieces; multifocal stenosis of the right common iliac vein and occlusion of the left common iliac and external iliac venous system with extensive collateralization.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 inferior vena cava (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.Ivc filter tilt has been associated with operator technique and/or vessel anatomy, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.The trapease vena cava filter is designed for permanent implantation.Endothelialization has been shown to occur in as short a period as twelve days.Post-thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, leading to swelling and/or pain of the affected extremity.Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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 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, tilting, filter is embedded and unable to be retrieved, caval thrombosis, thrombosis/embolism, post thrombotic syndrome, leg swelling and pain post implant.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, pain and suffering and other damages.Per the implant records, the patient was reported to have a preoperative diagnosis of extensive deep vein thrombosis (dvt) and failure of anticoagulation therapy.Both groins prepped and draped in an appropriate manner.The right common femoral vein was puncture with a needle.An inferior vena cavogram was performed demonstrating the entrance of both right and left renal veins.The vena cava measured less than 28mm in diameter and was free of thrombus.The trapease filter was then deployed below the entrance of the left renal vein in the inferior vena cava (ivc).The patient tolerated the procedure well.Approximately eleven years and six months after the filter was implanted, the patient underwent evaluation and attempted removal of indwelling ivc filter, in addition to venography with recanalization and stenting of the ivc, venography and angioplasty of the right common iliac vein and venography of the left common femoral vein.The medical history at the time was noted as complex prothrombotic history including protein c and protein s deficiency with recurrent venous thromboembolism, hypertension, leg swelling, recurrent dvt pain and decreased mobility.The patient underwent a technically challenging complex endovascular procedure with initial attempts to remove the permanent trapease filter which were eventually deferred due to inability to successfully centralized the inferior aspect of the filter within the laser sheath.The patient tolerated the procedure well.There were no immediate complications.The evaluation findings included a widely patent right internal jugular vein, right common femoral vein and left common femoral vein; a filter within the infrarenal cava with extensive chronic thrombotic and fibrotic material occluding the right aspect of the filter and surrounding the inferior and superior pieces; multifocal stenosis of the right common iliac vein and occlusion of the left common iliac and external iliac venous system with extensive collateralization.Following the prolonged intervention as described above, the ivc filter remained in situ with a stent complex extending through the filter from the infrarenal to the suprarenal cava.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately eight years and nine months after the filter was implanted.The patient reports tilting, filter embedded, blood clots, clotting and or occlusion of the ivc.The patient also reports undergoing an unsuccessful device retrieval procedure attempted approximated eleven years and six months after implantation.Additionally, a computerized tomography (ct) scan of the trapease ivc filter reported tilting, embedment, caval thrombosis, thrombosis/embolism, and post thrombotic syndrome.The patient further asserts to have suffered from leg swelling and pain post implant.These injuries have caused emotional distress, mental anguish, anxiety and stress.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 10395205
• MDR Text Key: 202513109
• Report Number: 1016427-2020-04272
• 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
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR