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

Catalog Number 466P306AU

Device Problem Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Thromboembolism (2654); Thrombosis/Thrombus (4440)

Event Date 10/29/2019

Event Type  Death  

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, perforation of filter struts beyond the wall of the inferior vena cava (ivc), perforation into surrounding organs/tissues and thrombosis/embolism.It was also reported that the patient is deceased; however, a cause of death nor a relationship to the device was provided.The indication for the filter implant has not been provided and there is currently 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.Blood clots, clotting and/or occlusion of the inferior vena cava (ivc), vasculature or the filter do not represent a device malfunction.Due to the nature of the complaint the report of thrombosis/embolism could not be further clarified.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported filter tilt and perforation could not be confirmed or further clarified.Due to the nature of the complaint and limited information provided, the cause of death and the relationship between the patient death and the filter could not be established.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

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, perforation of filter struts beyond the wall of the inferior vena cava (ivc), perforation into surrounding organs/tissues and thrombosis/embolism.It was also reported that the patient is deceased; however, a cause of death nor a relationship to the device was provided.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.

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, perforation of filter struts beyond the wall of the inferior vena cava (ivc), perforation into surrounding organs/tissues and thrombosis/embolism.It was also reported that the patient is deceased; however, a cause of death nor a relationship to the device was provided.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 post anesthesia care unit nursing documentation records, the right groin was accessed under general anesthesia for the trapease inferior vena cava (ivc) filter placement.Approximately seven years and five months after the filter was implanted, the patient underwent an abdominal computerized tomography (ct) scan indicated for filter evaluation.The scan reported the superior end of the cordis trapease ivc filter at the l2-l3 interspace.The ivc filter is tilted medially at the superior end and it does not contact the ivc wall.The ivc filter is not tilted at the inferior end.The scan noted the infrarenal ivc filter perforating through the ivc with multiple struts extending extraluminal.All the struts of the ivc filter perforating the ivc up to 7mm.One anterior strut perforates the ivc wall 6mm and contacts the bowel; a medial strut perforates the ivc wall 5mm and resides within the soft tissues.Two posterior struts perforate the ivc wall 5mm and 7mm and contact the l3 vertebral body; additionally, two lateral struts perforate the ivc wall 4mm and 6mm and contact the bowel.Eccentric thrombus was seen along the posterior and medial wall of the ivc and no fracture fragments were identified.The report also indicated that the original function of this ivc filter is permanent; therefore, it could not be removed by a percutaneous approach.According to the information received in the patient profile form (ppf), the next of kin reported perforation of filter struts outside the ivc, perforation of struts into organs, tilting and thrombus along the posterior and medial wall of the ivc, becoming aware of these events approximately thirteen years after the patient was implanted with the filter.The patient is deceased; a cause of death has not been provided; as such, a relationship between the event and the device cannot be established.

Manufacturer Narrative

As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement was not reported.Per the post anesthesia records, the right groin was accessed under general anesthesia for the trapease inferior vena cava (ivc) filter placement.The filter subsequently malfunctioned including ivc thrombosis, venous thrombosis, embolism, filter tilt, ivc and organ perforation and death.Approximately 7.5 year post implant, a ct scan revealed the superior end of the filter at the l2-l3 interspace.The filter is tilted medially at the superior end and it does not contact the ivc wall.The ivc filter is not tilted at the inferior end.The scan noted the infrarenal ivc filter perforating through the ivc with multiple struts extending extraluminal.All the struts of the ivc filter perforating the ivc up to 7mm.One anterior strut perforates the ivc wall 6mm and contacts the bowel; a medial strut perforates the ivc wall 5mm and resides within the soft tissues.Two posterior struts perforate the ivc wall 5mm and 7mm and contact the l3 vertebral body; additionally, two lateral struts perforate the ivc wall 4mm and 6mm and contact the bowel.Eccentric thrombus was seen along the posterior and medial wall of the ivc and no fracture fragments were identified.The report also indicated that the original function of this ivc filter is permanent; therefore, it could not be removed by a percutaneous approach.Per the patient profile form (ppf), it was reported that there was perforation of filter struts outside the ivc, perforation of struts into organs, tilting and thrombus along the posterior and medial wall of the ivc.The patient is deceased; a cause of death has not been provided.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 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.Blood clots, thrombosis, embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc and organs; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Death is a known potential complication associated with the use of the ivc filter devices and is listed in the ifu as such; however, in this case the cause of death was not reported; therefore, an adequate assessment of the relationship of the filter to the event of death is not possible.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 11265781
• MDR Text Key: 229830036
• Report Number: 1016427-2021-04745
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2009
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0606386
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR