MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306AU

Device Problems Failure to Align (2522); Unintended Movement (3026)

Patient Problems Weakness (2145); Injury (2348); Numbness (2415)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, the patient underwent placement of an trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the device.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.

Event Description

As reported by the legal brief, the patient underwent placement of an trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the device.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

As reported by the legal brief received, the patient underwent placement of an trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt of the device.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.The following is additional information received per the medical records and the patient profile form (ppf): device unable to be retrieved however no known attempts to remove the filter have been made, numbness in my left leg and left leg is uncoordinated and weak.

Manufacturer Narrative

It was reported that a 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, tilt of the device.The patient also reported that the filter can¿t be retrieved, however, there are no documented attempts to retrieve the filter.In addition, the patient reports that they have numbness in the left leg and the left leg is weak and uncoordinated.The indication for the filter placement was deep vein thrombosis with a contraindication to anticoagulation due to an intracerebral bleed.The filter was placed via the right femoral vein and deployed with the top of the filter being about one centimeter below the adjoining renal veins.The patient took several deep breaths in valsalva maneuver and there was no movement of the filter.The patient was transported to the recovery room in satisfactory condition.There is currently no additional information available for review.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 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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.Without images or procedural films for review, the reported filter tilt could not be confirmed, and the exact causes could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.The timing and mechanism of the tilt has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Left leg numbness and weakness do not represent a device malfunction and may be related to underlying patient issues, specifically in this case, the issue may be related to the prior intracranial bleed experienced by the patient, however with the limited information provided it is not possible to draw a conclusion as to the cause of the event(s).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.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7837405
• MDR Text Key: 118939944
• Report Number: 1016427-2018-01759
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0907470
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR