MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Failure to Align (2522); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown.  as reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, tilt, malformation, and cannot be retrieved.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not 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 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 films for review, the reported retrieval difficulty/malformation could not be confirmed and the exact cause could not be determined.Retrieval of the optease 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.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 malformation of the implanted filter.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 12 days.Additionally, the timing and mechanism of the tilt has not been reported at this time.Patient, technique or procedural factors during the attempted retrieval may have contributed to the reported tilt.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.  please note that this is the initial/final letter for this product file.

Event Description

As reported through the legal department via a legal brief, the plaintiff underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the plaintiff, including, but not limited to, tilt, malformation, and cannot be retrieved.As a direct and proximate result of these malfunctions, the plaintiff suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, tilt, malformation, the device cannot be retrieved and the patient is experiencing anxiety related to the device.The information received indicates that the patient became aware of these issues approximately twelve years after the device was implanted.At some time within the same month as the filter was implanted, the patient underwent an unsuccessful attempt to retrieve the filter.The details of the extraction attempt have not been provided.The indication for the device implant was a history of deep vein thrombosis (dvt) and anal cancer.The device was implanted via the right common femoral vein within the infrarenal area of the inferior vena cava.The patient was reported to have tolerated the index procedure well without visible or stated complications.There is currently no additional information available.The product was not returned for analysis and the sterile lot number provided is invalid; 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 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 opteese 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 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 12 days.Without images or procedural films for review the reported tilt, deformation and retrieval difficulty could not be confirmed.Clinical factors that may have influenced any reported events include underlying patient co-morbidities, pharmacological and lesion characteristics.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.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tiperrary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel co., tiperrary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6661630
• MDR Text Key: 78230172
• Report Number: 1016427-2017-00385
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/09/2017
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 01/19/2018; 02/20/2018
• Supplement Dates FDA Received: 02/17/2018; 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR