MAUDE Adverse Event Report: CORDIS DE MEXICO UNKNOWN VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number UNKFILTER

Device Problems Fracture (1260); Inflation Problem (1310)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Dyspnea (1816); Emotional Changes (1831); Failure of Implant (1924)

Event Date 09/29/2017

Event Type  Injury  

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 filter fracture and perforation of inferior vena cava (ivc) wall.According to the information received in the patient profile form, the patient became aware of the reported events twelve years and five months post implant.The patient also reports mental anguish, abdominal and chest pain, and shortness of breath.According to the implant record the indication for the filter placement was a history of deep vein thrombosis (dvt).The filter was placed via the right internal jugular vein and an inferior vena cavagram was obtained using power injection.The renal veins were identified, and the catheter positioned below the renal veins for subsequent filter placement.The catheter was advanced below the renal veins and the initial filter placed did not fully expand.The inferior vena cavagram demonstrated the filter was in a vertically oriented lumbar vein.A second filter was then deployed above the lumbar vein, but below the renal veins to be adequately aligned in the inferior vena cava and at the same time trap the misplaced filter in the lumbar vein.Follow-up venogram demonstrates both filters in expected position.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 sterile lot number for the filter placed in the lumbar vein was 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 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.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Without procedural or post implant films or images for review the reported event(s) could not be confirmed.With the limited information provided it is not possible to determine what factors may have contributed to the inaccurate placement and under expansion of the initial filter.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.Anxiety pain and shortness of breath do not represent a malfunction and may be related to underlying patient specific issues.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 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 damage, including, but not limited to filter fracture and perforation of inferior vena cava (ivc) wall.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.According to the information received in the patient profile from (ppf), the patient became aware of the reported events twelve years and five months post implantation.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture, and perforation of filter strut(s) outside the ivc.The patient also reports mental anguish, abdominal and chest pain, and shortness of breath.The following additional information received per the medical records state that the patient has a medical history of deep vein thrombosis.During the implant procedure, the right internal jugular vein was accessed.An inferior vena cavagram was obtained using power injection.The renal veins were identified and the catheter positioned below the renal veins for subsequent filter placement.The catheter was advanced below the renal veins and the initial filter placed did not fully expand.The inferior vena cavagram demonstrated the filter was in a vertically oriented lumbar vein.A second filter was then deployed above the lumbar vein, but below the renal veins to be adequately aligned in the inferior vena cava and at the same time trap the misplaced filter in the lumbar vein.Follow-up venogram demonstrates both filters in expected position.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9455686
• MDR Text Key: 170933438
• Report Number: 9616099-2019-03397
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKFILTER
• Device Catalogue Number: UNKFILTER
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR