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	Coagulation Disorder (1779); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
Date of Event	06/22/2003
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported in the legal brief, a patient was noted to have a cordis filter per scan imaging done.The type of filter was not identified.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, the patient is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment due to long term implant of the ivc filter.The patient suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability and other losses, not limited to the apprehension and risk associated with retaining a defective device inside the body.The referenced filter was identified as a trapease vena cava filter.Additional information received per the patient profile form (ppf) states that the patient experienced filter perforation, tilt, filter embedded in wall of the inferior vena cava (ivc), blood clots, clotting (both legs and groin), and/or occlusion of the inferior vena cava (ivc).The patient became aware of blood clots in both legs and groin starting three days after the filter was implanted.The patient sought treatment in the emergency department multiple times over the next five years.Five years after the filter was implanted the patient was diagnosed with chronic post thrombotic syndrome (cpts).They reported that the blood clots had destroyed their valves which subsequently caused frequent leg swelling and feet aches/pain.Approximately sixteen years and one month after the index procedure the patient became aware of filter tilt and filter perforation.An abdominal computed tomography (ct) scan for filter evaluation was done approximately sixteen years and one month after the index procedure.The cranial tip of the filter is slightly tilted anteriorly and the caudal tip is slightly tilted posteriorly.All struts are seen piercing through the vena cava walls.The struts are intact without significant migration or adjacent structures.No significant stenosis of the distal vena cava was seen.There is mild elevation of the right hemidiaphragm.There is also mild fatty infiltration of the liver.There are scattered vascular calcifications.
Additional Manufacturer Narrative
Initial reporter occupation: other, senior counsel, litigation.Event date: please note that the exact event date is unknown and the event date is the complaint awareness date.(b)(4).It was reported that a patient had a trapease vena cava filter implanted.The indication for the filter implant, procedural details and medical history of the patient have not been provided.The patient reported filter tilt, embedded, blood clots, clotting and/or occlusion of the inferior vena cava.The patient became aware of blood clots in both legs and groin starting three days after the filter was implanted and made multiple trips to the emergency department over the next five years, for the same issue.Five years post implant the patient was diagnosed with chronic post thrombotic syndrome and reported that the blood clots destroyed the valves which subsequently caused frequent leg swelling and feet aches and pains.Approximately sixteen years and one month post implant an abdominal computed tomography (ct) scan was performed to evaluate the filter.Results of the scan review noted that the cranial tip of the filter is slightly tilted anteriorly, and the caudal tip is slightly tilted posteriorly.All struts are seen piercing through the vena cava walls.The struts are intact without significant migration or adjacent structures.No significant stenosis of the distal vena cava was seen.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 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 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.Following implant, the predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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.Trapease ivc filters are indicated for permanent placement.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).Large thrombus within the vena cava and/or lower extremities may impede perfusion and cause venous insufficiency, also manifested by chronic leg swelling, pain, redness and ulcers.Blood clots, clotting, and thrombosis and/or occlusion within the device or the ivc and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.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.There is nothing in the information reported to suggest that there is an issue 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.Please note that this is the initial/final report for this product.

• 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 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14420327
• Report Number: 9616099-2022-05633
• Device Sequence Number: 17505564
• 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: 2003
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 03/31/2006
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0403224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/17/2022
• Date Device Manufactured: 04/16/2003
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 37 YR
• Patient Sex: Male