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

Catalog Number 466FXXXX

Device Problems Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Perforation (2001); Thrombosis/Thrombus (4440)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of an optease vena cava filter.The indication for filter insertion has not been provided.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation and thrombus present within the filter.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 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.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 complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots 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.Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to perforation and thrombus present within the filter.As a direct and proximate result of these malfunctions, 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.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.Approximately five years after the filter implantation, the patient became aware that the filter had tilted, had developed thrombus within it and was associated with perforation.Approximately six years after the filter implantation, the patient underwent a computerized tomography (ct) scan that demonstrated a filter in situ.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported filter tilt and perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Thrombosis within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.Section a3: correct patient gender is female.
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Event Description

Additional information received per the patient profile form (ppf) states that the patient experienced tilt and thrombus.The patient became aware of the reported events approximately five years after the index procedure.Abdominal/pelvis computed tomography (ct) scans done approximately six years after the index procedure show a cordis type filter in place.No other information can be gleaned from the image.

Event Description

Approximately five years after the index procedure a radiology scan was conducted for an indication of periumbilical abdominal pain.The scan revealed mild atherosclerotic changes in the visualized abdominal aorta.The filter was seen and it was suspected that the filter was trapping thrombus.Medical records state that the patient was admitted to the hospital approximately six years after the index procedure.The admitting diagnosis were gastrointestinal bleeding and abdominal pain.The patient was also experiencing anemia.The next day the patient had a radiological scan that revealed the following: small hiatal hernia, colonic diverticulosis, degenerative changes in the spine including lower lumbar facet arthropathy, scattered atherosclerotic calcification and small calcified granuloma in the posterior lateral right lower lobe.The filter was seen.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, b5, b6, g3, g6, h1 and h2.As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and thrombus present within the filter.The patient reported becoming aware of the tilt and thrombus approximately five years post implant.Approximately five years post implant a radiology scan was conducted for an indication of periumbilical abdominal pain.The filter was seen, and it was suspected that the filter was trapping thrombus.A computed tomography (ct) scan report indicated that approximately six years and eleven months post implant the patient experienced lower abdominal pain, rectal bleeding and anemia.Results of the scan noted no acute abnormality and the presence of the ivc filter.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported filter tilt and perforation events could not be confirmed, and the exact cause could not be determined.Ivc filter tilt has been associated with vessel characteristics, specifically asymmetry and tortuosity and technique.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Thrombosis within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and vessel characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12064310
• MDR Text Key: 258309268
• Report Number: 1016427-2021-05017
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 89 YR