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

Model Number 466P306AU

Device Problem Unintended Movement (3026)

Patient Problem Perforation of Vessels (2135)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and tilting.The patient reported becoming aware of the events approximately fourteen years and seven months post implant.The patient also reported chest pain, shortness of breath and anxiety related to the filter.According to the implant record the indication for the filter implant was deep vein thrombosis and pulmonary embolism.The filter was placed via the right femoral vein and successfully deployed in the inferior vena cava (ivc) proximal to the iliac bifurcation and distal to the renal vein insertion.Prior to deploying the filter, a venogram of was performed and revealed patency of the left common and external iliac veins as well as the left common femoral vein.The left superficial femoral vein was patent to the middle of the mid-thigh; however, there appeared to be a thrombotic occlusion in the distal portion.The plan was to perform angiojet thrombectomy, but due to the inability to safely pass the wire distally, the plan was abandoned.The patient tolerated the procedure well without any complications and it was recommended to resume lovenox and coumadin therapy and to plan for removal of the ivc filter in approximately four weeks depending on patient progress and recovery.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 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 filter tilt and perforation could not be confirmed or further clarified.Chest pain, shortness of breath and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.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 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 perforation and tilting.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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the filter was indicated for deep vein thrombosis (dvt) and pulmonary embolism (pe).Both groins were prepped in a sterile fashion.Using modified seldinger technique, a delivery sheath was inserted into the right femoral vein.Through this, venography was performed revealing patency of the left common and external iliac veins as well as the left common femoral vein.The left superficial femoral vein was patent to the middle of the mid-thigh; however, there appeared to be a thrombotic occlusion in the distal portion of the left superficial vein.The initial plans were to obtain a wire into the distal popliteal vein and possibly perform angiojet thrombectomy, but due to the inability to safely pass the wire distally, further attempts were abandoned.Of note, the medical records provided for review included an implant label for a cordis trapease filter; however, according to the operative report, an "optease" ivc filter was inserted and successfully placed in the inferior vena cava (ivc) proximal to the iliac bifurcation and distal to the renal vein insertion.The patient tolerated the procedure well without any complications and was recommended to resume lovenox and coumadin therapy post procedure and to plan for removal of the "optease" ivc filter in approximately four weeks depending on patient progress and recovery.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc and tilting of the filter, becoming aware of these events approximately fourteen years and seven months after the filter implantation, and further experienced chest pain, shortness of breath and anxiety related to the filter.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12347890
• MDR Text Key: 267450452
• Report Number: 1016427-2021-05318
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2008
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0805074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Date Device Manufactured: 08/10/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK 6F DELIVERY SHEATH, UNK GLIDEWIRE; UNK 6F SHORT SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR