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

Catalog Number 466P306X

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

Patient Problems Coagulation Disorder (1779); Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date in section b3 is the complaint awareness date.(b)(4).As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused occlusion and severe stenosis of the inferior vena cava (ivc) below the filter and chronic thrombus.An unsuccessful filter retrieval surgery was performed that required the use of forceps.Complete caval occlusion below the filter tip was found.Due to the chronically occluded ivc and chronic deep vein thrombosis (dvt), the patient underwent iliocaval reconstruction.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.The predominant concern for retrieval difficulty is 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.The trapease ivc filter is intended for permanent placement.Stenosis, an abnormal narrowing of a vessel, blood clots, clotting, and thrombosis and/or occlusion within the device or the ivc and/or the vasculature does not represent a device malfunction.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.Ivc filters are not indicated for use in the prevent of dvt.Breathing difficulties, fatigue and chest pain do not present a device malfunction and may be related to underlying patient specific issues and comorbidities, such as prior chest trauma.There is nothing to suggest that the reported events are 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.Please note that this is the initial report for this product.

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 specific evidence that there was occlusion and severe stenosis of the inferior vena cava (ivc) below the filter and chronic thrombus.An unsuccessful filter retrieval surgery was performed that required the use of forceps.Complete caval occlusion below the filter tip was found.Due to the chronically occluded ivc and chronic deep vein thrombosis (dvt), the patient underwent iliocaval reconstruction.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

As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused occlusion and severe stenosis of the inferior vena cava (ivc) below the filter and chronic thrombus.An unsuccessful filter retrieval surgery was performed that required the use of forceps.Complete caval occlusion below the filter tip was found.Due to the chronically occluded ivc and chronic deep vein thrombosis (dvt), the patient underwent iliocaval reconstruction.Approximately seventeen years after the index procedure there was an unsuccessful open abdominal removal attempt, although the medical records indicate a percutaneous procedure.The form also states that there are four struts outside the groin area, but no attempts to remove them had been performed.The patient experienced filter fracture, filter embedded in wall of inferior vena cava (ivc), blood clots, clotting and/or occlusion of the ivc.The patient became aware of the reported events approximately nineteen years and five months post implant.The patient reported that they developed atrial fibrillation, varicose veins, pain, swelling and depression related to the filter.According to the medical records the patient had a history of cholecystectomy, gastric bypass, hysterectomy, atrial fibrillation, deep vein thrombosis (dvt) and myocardial infarction.Approximately seventeen years after the index procedure there was an unsuccessful percutaneous removal attempt.An inferior venocavogram performed prior to removal attempt noted that the ivc was occluded just below the filter tip.During the procedure, attempts to advance a french sheath were unsuccessful.The sheath became deformed and did not have enough pushability to collapse the filter.The procedure was abandoned, with no immediate complications.Approximately seventeen years and one month post implant the patient presented for iliocaval reconstruction for chronic occlusion of the ivc in the region of the filter and chronic dvt of the iliac veins.After gaining access from the right and left common femoral veins, wires were advanced through the filter and balloon angioplasty was performed through the filter and bilateral common and external iliac veins.Non-cordis (zilver) stents were then simultaneously deployed across the ivc filter and post dilated.Non-cordis stents were then placed peripherally and bilaterally extending down into the common iliac veins.There were persistent areas of constriction observed within the stents that crossed the filter.Therefore, bilateral balloon expandable stents were simultaneously deployed within the existing stents across the filter.A follow up venogram showed excellent flow through the stents.Approximately nineteen years and six months after the index procedure months the patient underwent successful pharmacochemical angio jet thrombectomy of the right iliac vein and caval stents with bilateral balloon angioplasty of the iliocaval stents and extension of bilateral stents (non-cordis) into the external iliac veins for interval thrombosis of the right sided iliocaval stents and severe stenosis in the external iliac veins bilaterally, peripheral to the existing stents.Filter tilt was also observed.The product remains implanted and thus not available 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.The predominant concern for retrieval difficulty is 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.The trapease ivc filter is intended for permanent placement.Stenosis, an abnormal narrowing of a vessel, blood clots, clotting, and thrombosis and/or occlusion within the device or the ivc and/or the vasculature does not represent a device malfunction.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.Ivc filters are not indicated for use in the prevent of dvt.The ifu also states that 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 images available for review and the limited information provided the evens could not be confirmed or further clarified.Atrial fibrillation, pain, swelling, and depression do not represent a device malfunction and may be related to underlying patient specific issues and comorbidities.There is nothing to suggest that the reported events are 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 cholecystectomy, gastric bypass, hysterectomy, atrial fibrillation, deep vein thrombosis (dvt) and myocardial infarction.Approximately seventeen years after the index procedure there was an unsuccessful percutaneous removal attempt.An inferior venocavogram performed prior to removal attempt noted that the inferior vena cava (ivc) was occluded just below the filter tip.During the procedure, attempts to advance a french sheath were unsuccessful.The sheath became deformed and did not have enough pushability to collapse the filter.The procedure was abandoned, with no immediate complications.Approximately seventeen years and one month after the index procedure the patient presented for iliocaval reconstruction for chronic occlusion of the ivc in the region of the filter and chronic dvt of the iliac veins.After gaining access from the right and left common femoral veins, wires were advanced through the filter and balloon angioplasty was performed through the filter and bilateral common and external iliac veins.Non-cordis (zilver) stents were then simultaneously deployed across the ivc filter and post dilated.Non-cordis stents were then placed peripherally and bilaterally extending down into the common iliac veins.There were persistent areas of constriction observed within the stents that crossed the filter.Therefore, bilateral balloon expandable stents were simultaneously deployed within the existing stents across the filter.A follow up venogram showed excellent flow through the stents.Approximately nineteen years and six months after the index procedure months the patient underwent successful pharmacochemical angio jet thrombectomy of the right iliac vein and caval stents with bilateral balloon angioplasty of the iliocaval stents and extension of bilateral stents (non-cordis) into the external iliac veins for interval thrombosis of the right sided iliocaval stents and severe stenosis in the external iliac veins bilaterally, peripheral to the existing stents.Filter tilt was also observed.Additional information received per the patient profile form (ppf) states that approximately seventeen years after the index procedure there was an unsuccessful open abdominal removal attempt, although the medical records indicate a percutaneous procedure.The form also states that there are four struts outside the groin area, but no attempts to remove them had been performed.The patient experienced filter fracture, filter embedded in wall of inferior vena cava (ivc), blood clots, clotting and/or occlusion of the ivc.The patient became aware of the reported events approximately nineteen years and five months after the index procedure.The patient reported that they developed atrial fibrillation, varicose veins, pain, swelling and depression related to the filter.

• Brand Name: UNKNOWN TRAPEASE
• 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 32574
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 32574 ; 7863138372
• MDR Report Key: 15365399
• MDR Text Key: 299357066
• Report Number: 9616099-2022-05952
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR
• Patient Sex: Female