MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306AU

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Stenosis (2263); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)

Event Date 02/26/2021

Event Type  Injury  

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 filter embedment, clot in filter, stenosis and caval thrombosis.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

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.(b)(4) 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 become embedded, and was associated with clot, stenosis and caval thrombosis.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 procedural films for review, the reported filter embedment could not be confirmed and the exact cause could not be determined.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.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.Stenosis and thrombosis 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.Please note that this is the initial report for this product.

Event Description

An amended patient profile form (ppf) was received which states that in addition to the previously reported events, the patient also experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient became aware of these reported events approximately sixteen years after the index procedure.

Manufacturer Narrative

As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter embedment, clot in filter, stenosis and caval thrombosis.The patient additionally reported becoming aware of tilt and fracture approximately sixteen years post implant.The patient also reported not being able to bend to the side and stents implanted due to the filter.The filter was removed approximately sixteen years post implant.According to the implant record the patient had bilateral femur fractures and had undergone previous repair of the right femur fracture.The filter was placed via the right femoral vein and deployed at the level of l3.The patient tolerated the procedure well.The patient has subsequently reported becoming aware of blood clots, clotting and/or occlusion of the inferior vena cava (ivc), approximately sixteen years after the index procedure.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 ivc 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 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Trapease ivc filters are indicated for permanent placement.Stenosis, blood clots, clotting and/or occlusion of the device or the vasculature do not represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without imaging available for review the reported event could not be confirmed or further clarified.The timing of the filter tilt and fracture is unknown.There is nothing to suggest that the reported event is related to the design and/or 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

As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter embedment, clot in filter, stenosis and caval thrombosis.The patient additionally reported becoming aware of tilt and fracture approximately sixteen years post implant.The patient also reported not being able to bend to the side and stents implanted due to the filter.The filter was removed approximately sixteen years post implant.According to the implant record the patient had bilateral femur fractures and had undergone previous repair of the right femur fracture.The filter was placed via the right femoral vein and deployed at the level of l3.The patient tolerated the procedure well.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 ivc 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 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Trapease ivc filters are indicated for permanent placement.Stenosis, blood clots, clotting and/or occlusion of the device or the vasculature do not represent a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without imaging available for review the reported event could not be confirmed or further clarified.The timing of the filter tilt and fracture is unknown.There is nothing to suggest that the reported event is related to the design and/or 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

Additional information received per the medical records indicate that the patient has a history of bilateral femur fractures.The filter was deployed via the patient's right femoral vein.The filter was advanced up into the inferior vena cava to the l3 level.The patient tolerated the procedure well.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt and fractured filter.The patient became aware of the reported events approximately sixteen years after the index procedure.The patient was unable to bend to the side and had stents placed because of the filter.The patient had the filter removed approximately sixteen years after the index procedure.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12677623
• MDR Text Key: 281132171
• Report Number: 9616099-2021-04977
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2007
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1104721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 GUIDE WIRE; UNKNOWN CANNULA; UNKNOWN OBTURATOR
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male