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

Model Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problems Perforation (2001); Bowel Perforation (2668)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received, it will be provided.Complaint conclusion: it was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter tilted and perforated the inferior vena cava and duodenum.The patient also reports experiencing anxiety.The indication for the filter implant was massive pulmonary embolism with saddle embolus post-surgery.The filter was placed via the femoral vein and deployed with the tip at the top of the l2 vertebral body.Approximately 10 years and 10 months post implant the patient became aware of the filter tilting and the perforation.The method used to diagnose the event(s) and the mechanism for informing the patient have not been provided.There is currently no additional information available for review.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 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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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 procedural or post implant films for review, the reported filter tilt and perforation could not be confirmed nor a cause for the event(s) determined.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousity.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 associated with ivc filters.It is unknown if the tilt contributed to the reported perforation.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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 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, emotional and physical damages from tilting and perforation of the filter and the resultant symptoms.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.The following additional information was received per the patient¿s implant records: indication for filter placement was massive pulmonary embolism with saddle embolus post-surgery.The filter was deployed with the tip at the top of the l2 vertebral body.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 10 years and 10 months post implantation.The patient reports perforation of filter strut(s) outside the ivc, perforation of filter strut(s) into organs (duodenum) and tilt.The patient also reports suffering from anxiety.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8404370
• MDR Text Key: 138257079
• Report Number: 1016427-2019-02604
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/08/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/08/2019
• 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: 7 FRENCH SHEATH
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 61 YR