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 Code	Failure of Implant (1924)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional 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 tilting of the inferior vena cava (ivc) filter.The indication for the filter placement, procedural details and medical history have not been provided and there is 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 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.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Without imaging available for review the event could not be confirmed nor a cause attributed.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 or Problem Description
As reported by 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 of the inferior vena cava (ivc) filter.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, and pain and suffering and other damages.
Additional 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 tilting of the inferior vena cava (ivc) filter.The patient reported becoming aware of the event approximately fourteen years and eight months post implant.According to the medical record the patient had a history of left foot surgery s/p fracture, recurrent deep vein thrombosis (dvt) of the left lower extremity and a series of small pulmonary embolisms (pe) despite coumadin, tobacco dependence, right inguinal hernia repair and polycythemia vera.The indication for the filter implant was progression of dvt in the left leg.The filter was placed via the right common femoral vein and deployed at the level of the fourth lumbar vertebrae, inferior to the renal veins.The patient tolerated the procedure well.Approximately fourteen years and eight months post implant a computed tomography (ct) scan of the abdomen was performed to evaluate the ivc filter.Results of the scan noted the filter is in good position just below the renal veins and is minimally tilted forward with the top of the filter abutting the anterior wall of the ivc and the inferior tip abutting the posterior wall of the ivc.The filter struts are intact and there is no significant perforation outside the wall of the ivc.Lumbar spondylosis and atherosclerosis were also observed.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 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.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.Without imaging available for review the event could not be confirmed nor a cause attributed.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 or Problem Description
Additional information received per the medical records indicate that the patient has a history of left foot surgery s/p fracture, recurrent deep vein thrombosis (dvt) of the left lower extremity and a series of small pulmonary embolisms (pe) despite coumadin, tobacco dependence, right inguinal hernia repair and polycythemia vera.The indication for the filter implant was progression of dvt in the left leg.The filter was placed via the right common femoral vein and deployed at the level of the fourth lumbar vertebrae, inferior to the renal veins.The patient tolerated the procedure well.Approximately fourteen years and eight months post implant a computed tomography (ct) scan of the abdomen was performed to evaluate the inferior vena cava (ivc) filter.Results of the scan noted the filter is in good position just below the renal veins and is minimally tilted forward with the top of the filter abutting the anterior wall of the ivc and the inferior tip abutting the posterior wall of the ivc.The filter struts are intact and there is no significant perforation outside the wall of the ivc.Lumbar spondylosis and atherosclerosis were also observed.Additional information received per the patient profile form (ppf) states that the tilted filter has moved and causes mental and physical pain.The patient reported becoming aware of filter tilt approximately fourteen years and eight months post implant.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 15174962
• Report Number: 9616099-2022-05889
• Device Sequence Number: 15024930
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2008
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0905339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male