MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 11/07/2007

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown; if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis, device is embedded and unable to be retrieved.The filter remains 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 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.

Event Description

As reported by the legal brief, the 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, deep vein thrombosis, device is embedded and unable to be retrieved.As a direct and proximate result of these malfunctions, the patient suffered life threatening injuries and damages and required 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.

Event Description

Additional information received per the medical records indicate that after surgery for orthopedic trauma, the patient developed right lower extremity deep vein thrombosis.Anticoagulants were contraindicated due to trauma.The filter was implanted for protection from thromboembolism.The filter was deployed via the patient's right common femoral vein.It was placed below the renal veins.The patient tolerated the procedure well.There were no apparent intraoperative complications.  a doppler ultrasound revealed vein thrombosis.A later attempt to remove the filter was unsuccessful.A triple loop snare was used to snare the hook at the bottom of the filter.The filter could not be disengaged from the walls of the vena cava.The procedure was discontinued and the filter remained in place.The patient tolerated the procedure well.There were no apparent intraoperative complications.Additional information received per the patient profile form (ppf) states that the patient experienced deep vein thrombosis, device unable to be retrieved, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc.The patient became aware of the reported events six weeks after the index procedure.Ten weeks after the index procedure, there was an unsuccessful attempt to remove the device.These events have caused emotional distress, mental anguish, anxiety and stress.

Manufacturer Narrative

After further review of additional information received.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication was right leg dvt following trauma and orthopedic surgery.The filter was deployed below the renal veins.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis, device is embedded and unable to be retrieved.After filter implant, an ultrasound revealed thrombosis.There was an unsuccessful removal attempt using a snare device; however, the filter could not be disengaged from the walls of the vena cava.The procedure was discontinued, and the filter remained in place.The patient tolerated the procedure well.There were no apparent intraoperative complications.Per the patient profile form (ppf), the patient reports dvt, device unable to be retrieved, filter embedded in wall of the ivc, blood clots, clotting, and/or occlusion of the ivc and anxiety.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 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 and vasculature do not represent a device malfunction.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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10204504
• MDR Text Key: 196855226
• Report Number: 1016427-2020-04090
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: R0607304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR