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

Model Number	466P306AU
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Stenosis (2263); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/06/2011
Type of Reportable Event	Death
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date in section is the complaint awareness date.(b)(4).As reported a patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused, limited to the superior end of the cordis filter was in the l2-l3 interspace; the filter was tilted laterally at the superior end and the hook contacted the inferior vena cava (ivc) wall.All the struts of the ivc filter perforated the ivc up to 6mm.Two (2) lateral struts perforated the ivc and contacted the aorta.The native lumen of the ivc was 10mm.The decedent underwent an angioplasty and stent placement dilation of the ivc procedure performed and within the central portion of the ivc filter approximately five years and ten months post implant.The lumen of the stent within the ivc filter did not appear to be patent.The patient is noted to be deceased, a relationship between the event and the device was not provided.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.Stenosis is an abnormal narrowing of a vessel either by a proliferation of plaque or thrombus.Stenosis does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.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 events could not be confirmed or further clarified.Due to the nature of the complaint and limited information provided, 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.Please note that this is the initial report for this product.
Event or Problem Description
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to the superior end of the cordis filter was in the l2-l3 interspace; the filter was tilted laterally at the superior end and the hook contacted the inferior vena cava (ivc) wall.All the struts of the ivc filter perforated the ivc up to 6mm.Two (2) lateral struts perforated the ivc and contacted the aorta.The native lumen of the ivc was 10mm.Decedent underwent an angioplasty and stent placement dilation of the ivc procedure performed and within the central portion of the ivc filter approximately five years and ten months after the index procedure.The lumen of the stent within the ivc filter did not appear to be patent.As a direct and proximate result of these malfunctions, the decedent suffered life-threatening injuries and damages, and required extensive medical care and treatment.The patient is deceased, but there was no information provided to relate their demise to the device.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.
Additional 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 vena cava filter.The report states that the filter subsequently malfunctioned and caused, limited to the superior end of the cordis filter was in the l2-l3 interspace; the filter was tilted laterally at the superior end and the hook contacted the inferior vena cava (ivc) wall.All the struts of the ivc filter perforated the ivc up to 6mm.Two (2) lateral struts perforated the ivc and contacted the aorta.The native lumen of the ivc was 10mm.The decedent underwent an angioplasty and stent placement dilation of the ivc procedure performed and within the central portion of the ivc filter approximately five years and ten months post implant.The lumen of the stent within the ivc filter did not appear to be patent.The patient is noted to be deceased, a relationship between the event and the device was not provided.The patient became aware of events approximately thirteen years post implant.A death certificate was provided listing the cause of death as natural in addition to coagulation deficit and intractable lymphedema.An autopsy was not performed.According to the medical record the indication for the filter implant was pulmonary embolism.The filter was implanted via a right femoral approach and deployed above the bifurcation, but below the left renal arteries.The patient tolerated the procedure well.Computed tomography (ct) scan images (performed at 6.5 years, 7.2 years and 9.8 years post implant) were submitted for additional review and indicate what was initially reported, filter tilt and perforation.The product remains implanted and unavailable 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.Stenosis is an abnormal narrowing of a vessel either by a proliferation of plaque or thrombus.Stenosis does not represent a device malfunction and may be related to vessel characteristics and/or patient factors.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 events could not be confirmed or further clarified.The cause of death was listed as natural.A natural death is one that occurs as a result of the aging process or disease state such as coronary disease, cancer and stroke to name a few.With the limited information it is not possible to determine a contributing factor for the patient death.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 or Problem Description
Additional information received per the medical records indicate that the patient has a history of pulmonary embolism (pe).The filter was implanted via a right femoral approach.The filter was placed above the bifurcation, but below the left renal arteries.The patient tolerated the procedure well.Computed tomography (ct) scan images (performed 6.5 years, 7.2 years and 9.8 years after implant) were submitted for additional review and indicate what was initially reported, filter tilt and perforation.Additional information received per the patient profile form (ppf) states that thirteen years after implant, the patient became aware of the following conditions: filter tilt and inferior vena cava (ivc) perforation.The death certificate states that the cause of death is natural.Other conditions listed include coagulation deficit and intractable lymphedema.There was no autopsy.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14844572
• Report Number: 9616099-2022-05765
• Device Sequence Number: 2382887
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2008
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0605816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CATHETER; UNKNOWN INTRODUCER SHEATH; UNKNOWN J WIRE; UNKNOWN NEEDLE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White