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

Model Number N/A

Device Problem Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Death (1802); Occlusion (1984); Perforation (2001); Thrombosis (2100); Perforation of Vessels (2135); Stenosis (2263)

Event Date 09/08/2019

Event Type  Death  

Manufacturer Narrative

Please note that device reported is atrapease vena cava filter and for which the catalog and lot numbers are not currently available.The device remains implanted and is not available for evaluation.Patient age and medical history were also not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.The patient is reported to have died but the exact date has not been provided.Please note that the contact is not a medical professional but a more accurate choice is not available.As reported, the patient was implanted with a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury, damage, and/or wrongful death the patient, including, but not limited to caval stenosis, caval thrombosis, ivc perforation, filter tilt & embedment.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.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.The predominant concern for embedding with in 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.Endothelialization has been shown to occur in as short a period as 12 days.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.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

A patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused injury, damage, and/or wrongful death the patient, including, but not limited to caval stenosis, caval thrombosis, ivc perforation, filter tilt & embedment.As a direct & proximate result, the patient suffered life-threatening injuries & damages & required extensive medical care & treatment.As a further proximate.Result, the patient has suffered & will suffer significant medical expenses, pain & suffering & other damages.

Event Description

Additional information received per the medical records state that the indication for filter placement was pulmonary embolism in a patient who is unable to take anticoagulation therapy for acute gastrointestinal (gi) bleeding.The filter was deployed via the patient's right common femoral vein.The filter was placed above the bifurcation of the and below the renal veins.There were no complications.A venocavogram showed good apposition to the wall and excellent placement.  additional information received per the patient profile form (ppf) states that the patient experienced perforation of the filter struts outside the inferior vena cava (ivc), tilt of the filter, filter embedded in wall of the ivc, blood clots, clotting and or occlusion of the ivc.The patient became aware of the reported events approximately eleven years and four months after the index procedure.The patient is deceased, but there was no indication if this was related to the device.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b5, b6, b7, d1, d4, g1, g3, g4, g7, h1, h2 and h6.A patient was implanted with a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was pulmonary embolism with contradiction to anticoagulation with an acute gastrointestinal (gi) bleed.The filter was deployed above the bifurcation of the and below the renal veins.A venocavogram showed good apposition to the wall and excellent placement.The filter subsequently malfunctioned including, but not limited to caval stenosis, caval thrombosis, ivc perforation, filter tilt & embedment, and death.Per the patient profile form (ppf), the patient reported perforation of the filter struts outside the ivc, tilt, embedded in wall of the ivc, blood clots, clotting and or occlusion of the ivc.The patient is deceased; however, no cause of death has been reported.The product was not returned for analysis.The dhr could not be completed.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.The predominant concern for embedding with in 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.Endothelialization has been shown to occur in as short a period as 12 days.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.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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
• MDR Report Key: 10436821
• MDR Text Key: 203842186
• Report Number: 1016427-2020-04294
• 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
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0308152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 90 YR