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

Catalog Number 466P306X

Device Problem Difficult to Remove (1528)

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 recurrent deep vein thrombosis, filter occlusion and complex removal involving multiple attempts.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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 12 days.Blood clots, dvt 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

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 recurrent deep vein thrombosis, filter occlusion and complex removal involving multiple attempts.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.

Event Description

Additional information received per the medical records indicate that the patient has a history of chest pain, hyperlipidemia, snoring, anxiety disorder, surgeries on back, neck and left knee and coronary artery disease (cad) with drug eluting stent (des) percutaneous coronary intervention (pci) to the left anterior descending artery (lad).The indication for filter placement was deep vein thrombosis post coronary pci and angiojet thrombectomy of the lower extremities.The filter was placed into the infrarenal are, there were no reported complications.Two weeks later the patient experienced acute deep vein thrombosis with embolism.The patient's medication was adjusted.Two years and eight months after the index procedure the patient had a surgical intervention for lumbar stenosis and disc herniation.Two weeks after that procedure, the patient experienced non-traumatic subarachnoid hemorrhage resulting in left sided weakness, occluded ivc due to the ivc filter, acute pe, bilateral dvt and right ventricle thrombus.The patient was treated with tpa infusion, mechanical thrombectomy, stent implantation of iliac arteries, dcb angioplasty and stenting of ivc and iliac veins.Next, a complex ivc filter removal via snare was done.  additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and or occlusion on the inferior vena cava (ivc).The patent underwent a complex filter removal two years and eight months after the index procedure.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b7, g3, g4, g7, h1, h2 and h6.Cont.Section b5: as reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of chest pain, arrhythmias, hyperlipidemia, snoring, anxiety disorder and back, neck and left knee surgeries.The patient¿s history also included coronary artery disease with previous angioplasty and stenting of the left anterior descending artery.The indication for the filter placement was reported to be a deep vein thrombosis after percutaneous intervention of the coronary artery(ies) and thrombectomy of the left lower extremities.The filter was placed in an infrarenal position without reported complications.Approximately two weeks after the filter implantation, the patient became aware that the filter was associated with a recurrent deep vein thrombosis (dvt) and filter occlusion.The patient¿s medications were adjusted.Approximately two years and eight months after the filter implantation, the patient underwent unrelated back surgery.Two weeks after this procedure, the patient developed blood clots, clotting and occlusion of the inferior vena cava (ivc).The patient had also experienced an acute pulmonary embolism (pe), bilateral dvt and right ventricular thrombus.The patient was treated with thrombolysis and underwent mechanical thrombectomy, angioplasty and stent placement of the iliac arteries, iliac veins and ivc.In addition, the patient underwent complex percutaneous removal of the filter with the use of a snare.The patient further reported having undergone multiple attempts to remove the filter; though documentation of only one attempt was provided.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 reported details indicate that retrieval was attempted approximately two years and eight months after implantation.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.Stenosis, blood clots, clotting, 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 the event include the patient¿s pre-existing comorbidities, pharmacological 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.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9813917
• MDR Text Key: 188497003
• Report Number: 1016427-2020-03911
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• 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: 03/09/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR