MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Thrombosis (2100); Perforation of Vessels (2135)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.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 filter tilt and several struts of the filter perforated the wall of the inferior vena cava (ivc).The patient reported becoming aware of filter tilt and perforation approximately ten years and nine months post implant.According to the medical records the indication for the filter implant was acute pulmonary embolism and high risk for falling and therefore not a candidate for anticoagulation.The filter was placed via the right common femoral vein and deployed at the level of l2.The patient tolerated the procedure well without immediate complications.Approximately nine years and two months post implant a computed tomography (ct) scan of the patient¿s abdomen was performed to evaluate the filter.Findings of the scan noted lateral struts project outside the ivc wall by approximately 1-2mm.A cresentic density is present within the lumen of the filter.The report indicated that it is calcification which could be associated with chronic thrombus.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.Blood clots, clotting and/or occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with the anatomy of the vessel, 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.It is unknown if the tilt contributed to the reported perforation.Without procedural films or post implant imaging available for review, the reported filter tilt and mesenteric perforation could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported events are 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/final report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter is tilted and several struts of the filter perforated the wall of the inferior vena cava (ivc).As a result of the malfunction, 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.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately ten years and nine months post implant.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of filter strut(s) outside the ivc and tilt.The following additional information received per the medical records state that the patient has a preoperative diagnosis of acute pulmonary embolism.During the implant procedure, the right common femoral vein was accessed.The filter was placed at the l2 level.The patient tolerated the procedure well without immediate complications.A computed tomography (ct) scan of the patient¿s abdomen was performed nine years and two months post implant.The filter was oriented parallel to the long axis of the ivc and tilted approximately 9 degrees to the right with respect to vertical.The upper tip of the filter was located 2.0 cm both low the confluence of the right renal vein and ivc.The lateral metallic struts project just outside of the ivc wall by approximately 1-2 mm.A crescentic density was present within the lumen of the filter, from approximately 7 o'clock to 9 o'clock.This calcification could be associated with chronic thrombus.There were no broken filter fragments or extensions into surrounding organs identified.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33152
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33152
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10043630
• MDR Text Key: 190521462
• Report Number: 1016427-2020-03991
• Device Sequence Number: 1
• Product Code: DTK
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR