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

Catalog Number 466P306AU

Device Problems Fracture (1260); Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165)

Event Date 08/20/2020

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 tilting, perforation of filter struts beyond the wall of the ivc, perforation into surrounding organs/tissues, embedment, fracture of one or more filter struts, and ivc stenosis.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 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.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.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.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 tilting, perforation of filter struts beyond the wall of the inferior vena cava (ivc), perforation into surrounding organs/tissues, embedment, fracture of one or more filter struts, and ivc stenosis.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

After further review of additional information received, the following sections have been updated accordingly.As reported, a patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was deep vein thrombosis (dvt), with risk of pulmonary embolism (pe).A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.The filter subsequently malfunctioned including tilting, ivc and organ perforation, embedment, fracture, and ivc stenosis.Approximately eight years post implant, a ct scan revealed the superior end of the filter at the l1-l2 space, with tilt.All the struts of the ivc filter perforate the ivc up to 12mm.Two (2) anterior struts perforate the ivc wall 4mm and 12mm and contacted the bowel.One (1) medial strut perforates the ivc wall 12mm and was embedded within the aorta.Two (2) posterior struts perforate the ivc wall 8mm and 9mm and reside within the soft tissues.One (1) lateral strut perforates the ivc wall 11mm and resides within the soft tissues.There are bilateral patent kissing iliac vein stents with the superior ends contacting the inferior aspect of the ivc filter.There was one (1) fractured medial strut and there was one (1) fractured posterior strut.Per the patient profile form (ppf), the patient reports tilt, perforation of filter struts beyond the wall of the inferior vena cava (ivc), perforation into surrounding organs, filter embedded other than wall of the ivc and filter fractures (one medial strut and one posterior strut).It was noted that there are bilateral patent kissing iliac vein stents with the superior ends contacting the inferior aspects of the ivc filter.The patient has also experienced pain and anxiety.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.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.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.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.Anxiety and pain do not represent a device malfunction and may be related to underlying patient related issues.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

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis, risk for embolization and pulmonary embolism.The filter was deployed via the patient's right common femoral vein.The filter was placed at the l2 level without complications.The patient tolerated the procedure well.The results of computed tomography (ct) scans done approximately eight years after the index procedure revealed that the superior end of the filter was at the l1-l2 space.The inferior vena cava (ivc) filter was tilted posteriorly and medially at the superior end and it contacted the ivc wall.The ivc filter was tilted anteriorly and laterally at the inferior end and it contacted the ivc wall.All the struts of the ivc filter perforate the ivc up to 12mm.Two (2) anterior struts perforate the ivc wall 4mm and 12mm and contacted the bowel.One (1) medial strut perforates the ivc wall 12mm and was embedded within the aorta.Two (2) posterior struts perforate the ivc wall 8mm and 9mm and reside within the soft tissues.One (1) lateral strut perforates the ivc wall 11mm and resides within the soft tissues.There are bilateral patent kissing iliac vein stents with the superior ends contacting the inferior aspect of the ivc filter.There was one (1) fractured medial strut and there was one (1) fractured posterior strut.  additional information received per the patient profile form (ppf) states that the patient experienced tilting, perforation of filter struts beyond the wall of the inferior vena cava (ivc), perforation into surrounding organs, filter embedded other than wall of the ivc and filter fractures (one medial strut and one posterior strut).It was noted that there are bilateral patent kissing iliac vein stents with the superior ends contacting the inferior aspects of the ivc filter.The patient became aware of the reported events approximately eight years after the index procedure.The patient has also experienced worry, fear of more clots slipping past the filter, stomach pain, lower abdominal pain.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b6, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 11280971
• MDR Text Key: 230342616
• Report Number: 1016427-2021-04754
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15616973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR