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

Model Number	466P306AU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
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 perforation by 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, pain and suffering, and other damages.Additional information received per the medical records indicate that the patient has a history of moderate venous insufficiency, superficial thrombophlebitis and morbid obesity.The filter was implanted prior to planned bariatric surgical procedure.The filter was implanted via the patient's right internal jugular vein (ijv).Ultrasound was used to cannulate the right ijv.A guide wire was passed through the ijv through the right atrium and ventricle into the internal vena cava (ivc).The filter was placed through the dilator sheath to the l3 level.The dilator sheath was withdrawn.Hemostasis was restored.The patient tolerated the procedure well and was in satisfactory condition.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported event approximately twelve years and six months after the index procedure.The patient also experienced stomach pain, stressful, feel depressed and worried.
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.
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 perforation by the inferior vena cava (ivc) filter.The patient reported becoming aware of perforation of filter struts outside the inferior vena cava (ivc) approximately twelve years and six months post implant.The patient also reported stomach pain, and depression related to the filter.According to the medical record, the patient had a history of moderate venous insufficiency, superficial thrombophlebitis and morbid obesity.The filter was implanted prior to planned bariatric surgery.The filter was implanted via the right internal jugular vein and deployed at the level of l3.The patient tolerated the procedure well and was in satisfactory condition.The product remains implant and therefore not available 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 trapease ivc filter is indicated for permanent placement.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.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.Without procedural films or post implant imaging available for review, the reported event could not be confirmed or further clarified.Pain and depression do not represent a device malfunction and may be related to underlying patient specific issues or comorbidities.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
• 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: 14160613
• Report Number: 9616099-2022-05562
• Device Sequence Number: 2943819
• 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: 2007
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0107542
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2007
• 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 DILATOR SHEATH; UNKNOWN GUIDE WIRE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White