MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

The catalog and lot number are unknown; if received, they will be provided.Without a lot number, device history record (dhr) review cannot be conducted.Complaint conclusion: as reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of head trauma.The indication for the filter placement was reported to be for a recent right lower extremity deep vein thrombosis (dvt).The filter was implanted via the right common femoral vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well.Approximately one month and thirteen days after the filter implantation, the patient underwent an unsuccessful percutaneous attempt to retrieve the filter.More than fourteen years after the filter implantation, the patient became aware that the filter had tilted and was associated with perforation that was abutting an organ.The patient further reported having experienced anxiety and worry associated with the filter.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 optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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.Without images or procedural films for review, the reported filter tilt, perforation and retrieval difficulty events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The reported details indicate that retrieval was attempted approximately one month and thirteen days after implantation.Retrieval of the optease retrievable vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as twelve days.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, malfunction, including perforation, tilt, and perforation abutting organ that causes injury and damage to the plaintiff.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 continue to suffer significant medical expenses, pain and suffering, and other damages.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately fourteen years and three months post implantation.The patient reports living with the anxiety of having a filter that could fail further at any time, but that cannot be retrieved without a second more serious surgery.The patient reports being worried because the filter has tilted within the vena cava and perforated outside of it.The patient also reports suffering from anxiety.According to the information received in the patient profile form (ppf), the filter was attempted to be removed approximately one month and 13 days post implantation but percutaneous removal was unsuccessful.Per the implant records, the filter was implanted due to right leg dvt.The filter was implanted successfully implanted in the infrarenal location and appeared adequate with no thrombus identified within the ivc.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 11076307
• MDR Text Key: 223725556
• Report Number: 1016427-2020-04663
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• 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: 12/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: No
• 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: COBRA CATHETER; LIDOCAINE 1%; UNKNOWN GUIDEWIRE; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR