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

Model Number 466P306X

Device Problems Fracture (1260); Difficult to Remove (1528); Unintended Movement (3026); Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Thrombus (2101)

Event Date 05/25/2019

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown; if received it will be provided.Complaint conclusion: 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 fracture of the inferior vena cava (ivc) filter, clotting and calcification of the ivc, and device unable to be retrieved.The indication for the filter placement, procedural details and medical history have not been provided and there is 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 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.Blood clots and occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Without procedural films or post implant imaging and the limited information available for review, the reported events could not be confirmed or further clarified.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.Given the limited information currently available for review, 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 filter subsequently malfunctioned and caused injury and damages including, but not limited to: fracture of the ivc filter, clotting and calcification of the ivc, and device unable to be retrieved.

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 fracture of the inferior vena cava (ivc) filter, clotting and calcification of the ivc, and device unable to be retrieved.The patient subsequently reported becoming aware of migration, tilt, filter embedded, blood clots, clotting and/or occlusion, opacification in the ivc, fractured struts and device unable to be retrieved with no documented attempts to remove the filter approximately five years post implant.The patient also reports extensive blood clots, thrombus stuck in the ivc filter, shortness of breath, pain and discomfort at the site of the filter, mental anguish, and permanent and ongoing complications.According to the medical record, the patient presented to one facility with increased pain and swelling of the right leg and was diagnosed with deep vein thrombosis.The patient had a conflict with the admitting physician at the facility, left and went to a different facility.Per the implant record, the patient had a history of recurrent dvt and pulmonary embolism (pe) and factor v leiden.The filter was placed via the right internal jugular vein and deployed in the infrarenal cava.There were no complications.Approximately five years post implant the patient underwent a duplex ultrasound (us).The ultrasound reported occlusive thrombus from the right femoral vein to the right proximal calf veins and nearly occlusive thrombus in the left common femoral vein to left femoral vein.One week later the patient underwent a computerized tomography (ct) scan of the abdomen and pelvis to evaluate for thrombus.The report indicated an ivc filter is present with thrombus within the filter.One of the filter struts is fractured, with fragments still in continuity with the remainder of the filter.The ivc below the filter is diminutive but patent.There is homogeneous opacification of the right common and external iliac veins and common femoral vein.Opacification of the left common and external iliac veins is slightly heterogeneous and there is thrombus in the left profunda femoris vein as described on recent dvt ultrasound.Incidental findings included a prominence of bilateral gonadal veins consistent with collateral flow; collateral veins also present in the rectus muscles and overlying subcutaneous fat.There is no additional information available for review.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.Blood clots and occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Collateral circulation develops as a result of inherent circulation patterns being impeded, such as chronic occlusive thrombus.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.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.Ivc filter tilt has been associated with practitioner technique, the anatomy of the vessel, specifically asymmetry and tortuosity.Ivc filter migration is a known potential adverse event associated ivc filters and is listed in the ifu as such.Possible causes for migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Without procedural films or post implant imaging and the limited information available for review, the reported events could not be confirmed or further clarified.Anxiety, shortness of breath and pain do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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 filter subsequently malfunctioned and caused injury and damages including, but not limited to: fracture of the ivc filter, clotting and calcification of the inferior vena cava (ivc), and device unable to be retrieved.Per the implant records, the patient was reported to have a history of recurrent deep vein thrombosis (dvt), pulmonary embolism (pe) and factor v leiden and presented increased right leg swelling and pain.The inferior vena cava was selected and an inferior venacavogram was obtained.The ivc filter was placed in the infrarenal cava.There were no complications.Approximately five years after the filter was implanted, the patient was known to have dvts with ivc filter on blood thinners and underwent a duplex ultrasound (us).The ultrasound reported occlusive thrombus from the right femoral vein to the right proximal calf veins.Nearly occlusive thrombus was seen in the left common femoral vein to left femoral vein.The patient then underwent a computerized tomography (ct) scan of the abdomen and pelvis indicated for thrombus evaluation with history of ivc thrombus.The findings reported on the ct scan included an ivc filter present with thrombus within the filter.One of the filter struts is fractured, with fragments still in continuity with the remainder of the filter.The ivc below the filter is diminutive but patent.There is homogeneous opacification of the right common and external iliac veins and common femoral vein.Opacification of the left common and external iliac veins is slightly heterogeneous and there is thrombus in the left profunda femoris vein as described on recent dvt ultrasound.Incidental findings included a prominence of bilateral gonadal veins consistent with collateral flow; collateral veins also present in the rectus muscles and overlying subcutaneous fat and a small kidney stone.According to the information received in the patient profile form (ppf), the patient reports migration and tilting of the filter; filter embedded in wall of the ivc; blood clots, clotting and or occlusion of the ivc; opacification in the inferior vena cava and veins; fractured filter struts retained in the inferior vena cava; device unable to be retrieved with no documented attempts to remove the filter.The patient reports becoming aware of the reported events approximately five years after the filter implantation, and further asserts to have suffered from extensive blood clots, thrombus stuck in the ivc filter, shortness of breath, pain and discomfort at the site of the filter, mental anguish, and permanent and ongoing complications.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10214514
• MDR Text Key: 197335646
• Report Number: 1016427-2020-04118
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 16058492
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 48 YR