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

Model Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problems Death (1802); Embolus (1830); Occlusion (1984); Perforation (2001); Thrombosis (2100); Stenosis (2263)

Event Date 06/14/2013

Event Type  Death  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.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, tilt, perforation, stenosis, and caval thrombosis.As a direct and proximate result of these malfunctions, patient suffered life threatening injuries and damages, and required extensive medical care and treatment.The information provided indicates the patient has deceased but does not indicate if the death is related to the inferior vena cava filter.

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, tilt, perforation, stenosis, and caval thrombosis.As a direct and proximate result of these malfunctions, patient suffered life threatening injuries and damages, and required extensive medical care and treatment.The information provided indicates the patient has deceased but does not indicate if the death is related to the inferior vena cava filter.

Manufacturer Narrative

Complaint conclusion: it was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt, perforation, stenosis, and caval thrombosis.The information provided also indicated that the patient is deceased, a cause of death was not 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.Blood clots and vessel stenosis do not represent a device malfunction, rather clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without procedural 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.The information indicated that the patient was deceased, with the limited information provided a clinical conclusion relating to the filter and the event could not be determined.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.Additional information was provided and is available in: (evaluation codes).The implant date was confirmed to be accurate.

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Additional information received per the medical records indicate that the patient has a history of lumbago with radicular pain and deep vein thrombosis with contraindication to long-term anti-coagulation therapy.Six hours prior to the index procedure, the patient's heartrate was over 150 beats per minute.The patient was taken to the intensive care unit and treated.After his heart rate was under 90 beats per minute, the filter was implanted.  the filter was deployed via the common femoral vein with difficulty.The vein was deep and crossed under the femoral arteries.The filter was placed in the proximal inferior vena cava below the level of the renal veins.The patient tolerated the procedure well.  additional information received per the patient profile form (ppf) states that during venous evaluation, it was reported the patient suffered from caval thrombosis.A later computed tomography (ct) scan performed for evaluation of his optease filter noted tilting of the filter, perforation of the filter strut(s) outside of the inferior vena cava and stenosis.The form also states that the patient experienced blood clots, clotting, and/or occlusion of the ivc.These injuries have caused emotional distress, mental anguish, anxiety and stress.It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt, perforation, stenosis, and caval thrombosis.The information provided also indicated that the patient is deceased, a cause of death was not provided.Additional information indicated that approximately two weeks post implant the patient experienced blood clots, clotting, and/or occlusion of the ivc.A venous duplex ultrasound revealed extensive bilateral deep vein thrombosis.At some point post implant computed tomography (ct) scan performed for evaluation of his optease filter and noted tilting of the filter, perforation of the filter strut(s) outside of the inferior vena cava and stenosis.The patient is reported to have experienced anxiety and stress related to these events.The medical records indicated that the patient experienced a tachycardic event prior to the filter implant, the patient was treated in the intensive care unit with intravenous lopressor and brought back to the angiography suite six hours later for the filter implant.The indication for the filter implant was deep vein thrombosis with contraindication to long-term anti-coagulation therapy.The filter was placed via the common femoral vein and deployed below the level of the renal veins.The patient reportedly tolerated the procedure well.Approximately two weeks post filter implant the patient had a lumbar spine x-ray for lumbago with radicular pain, the imaging noted that the ivc filter is in place, a metallic foreign object was identified in the right lower quadrant and degenerative disc changes were seen, there was no evidence of acute fracture or subluxation.There is currently no additional information available for review.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 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.Blood clots, clotting and/or occlusion related to clotting and vessel stenosis do not represent a device malfunction, rather clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Without procedural 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.The information indicated that the patient was deceased, with the limited information provided a clinical conclusion relating to the filter and the event could not be determined.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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• 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: 7921443
• MDR Text Key: 122149703
• Report Number: 1016427-2018-01894
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: 15789723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• 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): Death
• Patient Age: 53 YR