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

Model Number 466P306X

Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Perforation (2001); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to blood clots, stenosis, caval thrombosis, perforation and tilting.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 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; 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.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 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 blood clots, stenosis, caval thrombosis, perforation and tilting.As a direct and proximate result, 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

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 blood clots, stenosis, caval thrombosis, perforation and tilting.The patient reported becoming aware of these events approximately nine years and nine months post implant.The patient also reported experiencing two additional episodes of deep vein thrombosis, anxiety and suffering from post-partum depression.The patient has subsequently reported becoming aware of filter fracture approximately nine years and nine months post implant.According to the implant record the patient was on birth control pills and developed a deep vein thrombosis.The patient was hospitalized for a day or two, was anticoagulated and sent home.The patient returned to the emergency room a few days later with increased swelling and pain of the affected left leg.A computed tomography venogram was performed and demonstrated extensive thrombosis in the left iliac vein extending into the inferior vena cava (ivc), despite a therapeutic inr.The filter was placed due to the high risk for extension of the clot and possible pulmonary embolism.The filter was placed via the right internal jugular vein and deployed below the level of the renal veins.Prior to deployment a venogram showed the ivc was patent but at the distal end there appeared to be some negative images suggestive of thrombus.Approximately eleven years and three months post implant the patient underwent an unsuccessful percutaneous retrieval attempt, no additional details were provided.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 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 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 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.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.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Without procedural films or images for review the reported event(s) could not be confirmed.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Stenosis, a narrowing of a vessel, of the ivc is associated with all ivc filter products and does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filters are not indicated in for the prevention of deep vein thrombosis.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Without procedural films or images for review and the very limited information provided the reported event(s) could not be confirmed or further clarified.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

Additional information received per an amended patient profile form (ppf) states that in addition to the previously reported events, the patient also experienced filter fracture within the inferior vena cava.The patient became aware of the reported event nine years and nine months after the index procedure.

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 blood clots, stenosis, caval thrombosis, perforation and tilting.As a direct and proximate result, 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.The following additional information was received per medical records: the patient was unable to walk due to excruciating pain caused by a clot and right leg swelling/turning purple.The patient was hospitalized a few days later presenting with a massive formation of left leg dvt extending into the ivc despite adequate anticoagulation.A ct scan completed verified extensive thrombus in the left iliac vein extending into the ivc, lending to high risk for extension of the clot and possibly pulmonary embolism.Approximately 5 years prior to filter implantation, the patient underwent treatment in the er for blood clots.Using local and iv sedation, the patient underwent placement of an ivc filter via right jugular vein.Under fluoroscopic guidance, the renal veins were located and a venogram was taken.An optease ivc filter was deployed below the right renal vein (lower of the two) without issue.The procedure was completed successfully and without complication.The following additional information was received per patient profile form (ppf): the patient became aware of the reported events approximately 9 years and 9 months post implantation.The patient reports perforation of filter strut(s) outside the ivc, filter tilt, blood clots, clotting, and/or occlusion of the ivc, and stenosis.An attempt to remove the implanted ivc filter percutaneously was unsuccessful approximately 11 years and 3 months post implantation.The patient also reports suffering from anxiety and postpartum depression.

Manufacturer Narrative

Additional information: section a2 (age at the time of event, date of birth) section b3 (event date) section b5 (event description) section b7 (relevant medical history) section d11 (concomitant medical products: guidewire, sheath, 6fr system, pigtail catheter) section g4 (date received by the manufacturer) section h6 (evaluation codes: addition of patient codes 2135, 1984, and 1204.Addition of conclusion code 4310.) 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 blood clots, stenosis, caval thrombosis, perforation and tilting.The patient reported becoming aware of these events approximately nine years and nine months post implant.The patient also reported experiencing two additional episodes of deep vein thrombosis, anxiety and suffering from post-partum depression.According to the implant record the patient was on birth control pills and developed a deep vein thrombosis.The patient was hospitalized for a day or two, was anticoagulated and sent home.The patient returned to the emergency room a few days later with increased swelling and pain of the affected left leg.A computed tomography venogram was performed and demonstrated extensive thrombosis in the left iliac vein extending into the inferior vena cava (ivc), despite a therapeutic inr.The filter was placed due to the high risk for extension of the clot and possible pulmonary embolism.The filter was placed via the right internal jugular vein and deployed below the level of the renal veins.Prior to deployment a venogram showed the ivc was patent but at the distal end there appeared to be some negative images suggestive of thrombus.Approximately eleven years and three months post implant the patient underwent an unsuccessful percutaneous retrieval attempt, no additional details were provided.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 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 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 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.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.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Ivc filters are not indicated in for the prevention of deep vein thrombosis.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Without procedural films or images for review and the very limited information provided the reported event(s) could not be confirmed or further clarified.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: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9913288
• MDR Text Key: 188515164
• Report Number: 1016427-2020-03979
• 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,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 30 YR