MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN OPTEASE RETREIVABLE VENA CAVA FILTER; THROMBECTOMY SYSTEM

Model Number N/A

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Swelling (2091)

Event Date 11/13/2006

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.If obtained, a follow up report will be submitted within 30 days upon receipt.(b)(4).As reported in the legal brief, the patient underwent placement of the optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, failed retrieval attempt due embedment of the filter into the caval wall, leg swelling due to clogging of the filter, and being unable to have the filter retrieved.As a direct and proximate result of these malfunctions, the 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, and pain and suffering, and other damages.The product was not returned for analysis.Additionally, as the sterile lot number was not available, a device history record review could not be performed.The optease 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.Occlusion within the filter and blood clots do not represent a device malfunction.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency leading to swelling within lower extremities and pain.The legal brief noted that the filter was unable to be retrieved.The reported event does not note implantation or attempted removal of the device.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.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.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.

Event Description

As reported in the legal brief (b)(6), the patient underwent placement of the optease vena cava filter which subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, failed retrieval attempt due embedment of the filter into the caval wall, leg swelling due to clogging of the filter, and being unable to have the filter retrieved.As a direct and proximate result of these malfunctions, the 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, and pain and suffering, and other damages.

Manufacturer Narrative

Additional information was received that the patient presented for retrieval approximately 2 months after filter placement, at which time about 70% of the filter could be captured but the most proximal aspect of the filter could not be, because it had incorporated into the caval wall.Given the concern for further manipulation and possible laceration of the ivc, the surgeon opted to keep the filter in place as a permanent device and place her on coumadin indefinitely.A repeat venogram confirmed no change in the filter's location or tear in the ivc, although there had been some mild spasm of the renal veins associated with manipulation of the filter.Her quality of life is now severely impaired.Despite being intended as only a temporary device, plaintiff was advised that the filter could no longer be retrieved.The filter remains implanted.Plaintiff will require lifelong monitoring of her filter to ensure that it does not fracture, migrate, or further malfunction in some way, creating a life-threatening situation for plaintiff.Plaintiff must now live with constant worry and anxiety about the state of her health related to the filter.At filter placement, the patient presented with post hysterectomy complicated with post-operative embolus and bilateral ovarian vein thrombosis.Placement of the filter was compounded by suboptimal tilting of the ivc.The filter was snared and there was placement of another filter.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter.At filter placement, the patient presented with post hysterectomy complicated with post-operative embolus and bilateral ovarian vein thrombosis.Placement of the filter was compounded by suboptimal tilting of the ivc.The filter was snared and there was placement of another filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, a failed retrieval attempt, leg swelling, and filter occlusion.The patient presented for retrieval approximately 2 months after filter placement, at which time about 70% of the filter could be captured but the most proximal aspect of the filter could not be, because it was incorporated into the caval wall.The filter was left in place as a permanent device and the patient was placed on coumadin indefinitely.A repeat venogram confirmed no change in the filter's location or tear in the ivc, although there had been some mild spasm of the renal veins associated with manipulation of the filter.The filters remain implanted; thus, unavailable for analysis.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 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 filter tilt reported could not be confirmed.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 tortuousness.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 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 12 days.Blood clots and occlusive thrombosis within the filter do not represent a device malfunction.Swelling of the extremities and spasm of the renal veins do not represent a device malfunction and may be related to underlying patient related issues.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.This is one of two reports associated with this patient please note that this report is associated with report 1016427-2017-00580 and 1016427-2018-01612.

• Brand Name: UNKNOWN OPTEASE RETREIVABLE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEM
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co tipperary; cashel ; EI
• MDR Report Key: 6845383
• MDR Text Key: 85000191
• Report Number: 1016427-2017-00580
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/21/2017
• Date Manufacturer Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 47 YR