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

Model Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problems Embolus (1830); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263); No Code Available (3191)

Event Date 09/26/2018

Event Type  Injury  

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 tilt, perforation of all filter struts outside the wall of the ivc with multiple struts perforating into surrounding tissue/organs.The indication for the filter implant, procedural details and medical history have not been provided and there is currently no additional information available for review.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 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.Ivc filter tilt has been associated with the anatomy of the vessel, 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.It is unknown if the tilt contributed to the reported perforation.Without procedural films or post implant imaging available for review, the reported filter tilt and perforation of ivc and into surrounding tissue/organs could not be confirmed or further clarified.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 by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt.Perforation of all filter struts outside the wall of the ivc with multiple struts perforating into surrounding tissue/organs.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.

Event Description

Additional information received per the medical records indicate that the patient has a history of anemia secondary to bleeding, deep vein thrombosis in left were extremity and contraindication to anticoagulation therapy.The filter was deployed via the patient's right common femoral vein.It was placed above the confluence of veins, below the vein.The patient tolerated the procedure well.Computed tomography (ct) scans done approximately fifteen years and two months after the index procedure were re-evaluated sixteen years after the index procedure.The images revealed the superior end of the trapease inferior vena cava (ivc) filter was at the l2-l3 interspace.The ivc filter was tilted anteriorly at the superior end, but it does not contact the ivc wall.The ivc filter is tilted posteriorly at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 9mm.Two (2) anterior struts perforate the ivc wall both 5mm and contact the bowel.One (1) medial strut perforates the ivc wall 9mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 8mm and contacts the l3-l4 disc.One (1) lateral strut perforates the ivc wall 6mm and contacts the right gonadal vein.One (1) lateral strut perforates the ivc wall 5mm and resides within the soft tissues.The ivc is atretic inferior to the ivc filter.This study was also compared to ct scans done approximately fourteen years and four months after the index procedure.The superior end of the trapease filter was at the l2-l3 interspace.The ivc filter was tilted anteriorly at the superior end but it does not contact the ivc wall.The ivc filter was tilted posteriorly at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 9mm.Two (2) anterior struts perforate the ivc wall 4mm and 5mm and contact the bowel.One (1) medial strut perforates the ivc wall 9mm and resides within the soft tissues.One (1) posterior strut perforates the ivc wall 7mm and contacts the l3-l4 disc.Two (2) lateral struts perforate the ivc wall both 5mm and reside within the soft tissues.The ivc is atretic inferior to the ivc filter.  additional information received per the patient profile form (ppf) states that the patient experienced filter tilt, perforation of filter strut(s) outside the ivc, perforation of filter strut(s) into organs and the ivc is atretic inferior to the ivc filter.The patient stated that she has been hospitalized twice for blood clots and profuse bleeding.She noted that she takes blood thinners.The patient became aware of the reported events approximately fourteen years and four months after the index procedure.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b6, b7, d1, d4, d11, g3, g4, g7, h1, h2 and h6.Section h6: patient code '3191' was used for bleeding and  inferior vena cava atresia (circulatory collapse).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 tilt, perforation of all filter struts outside the wall of the inferior vena cava (ivc) with multiple struts perforating into surrounding tissue/organs.The patient reported becoming aware of filter tilt, perforation, the ivc is atretic inferior to the ivc filter, blood clots and bleeding approximately fourteen years and four months post implant.The patient was hospitalized twice for blood clots and profuse bleeding.The patient does take blood thinners.According to the implant record the indication for the filter implant was deep vein thrombosis of the left lower extremity, anemia due to bleeding and a contraindication to anticoagulation therapy.The filter was placed via the right common femoral vein and deployed at the level of l2.A high confluence of the common iliac veins was noted in the ivc and the filter was positioned above the confluence.The patient tolerated the procedure well.A computed tomography (ct) scan was performed approximately fifteen years and two months post implant and reevaluated sixteen years post implant.The images revealed the superior end of the filter was at the l2-l3 interspace.The ivc filter was tilted anteriorly at the superior end, but it does not contact the ivc wall.The ivc filter is tilted posteriorly at the inferior end and it contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 9mm.Two anterior struts contact the bowel.One medial and one lateral strut resides within the soft tissues.One posterior strut contacts the l3-l4 disc.One lateral strut contacts the right gonadal vein.The ivc is atretic inferior to the ivc filter.This study was also compared to ct scan done approximately fourteen years and four months post implant and noted similar findings.There is currently no additional information available for review.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 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, bleeding and atresia (stenosis) of the inferior vena cava (ivc) or the filter do not represent a device malfunction.Stenosis is an abnormal narrowing of a vessel.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with the anatomy of the vessel, 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.It is unknown if the tilt contributed to the reported perforation.Without procedural films or post implant imaging available for review, the reported filter tilt and perforation of ivc and into surrounding tissue/organs could not be confirmed or further clarified.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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10270898
• MDR Text Key: 198911930
• Report Number: 1016427-2020-04184
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0104396
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 7 FRENCH INTRODUCER; UNKNOWN CATHETER; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 83 YR