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

Catalog Number 466FXXXX

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

Patient Problems Embolus (1830); Perforation of Vessels (2135)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

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 retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter was associated with perforation of filter strut(s) outside the inferior vena cava and blood clots.The filter was also reported to have been irretrievable; though attempts to retrieve it were not documented.The patient further reported having experienced discomfort, shortness of breath, sleep apnea, chronic coughing and general respiratory issues associated with the 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 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 ivc perforation could not be confirmed and the exact cause could not be determined.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.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain, shortness of breath, sleep apnea, coughing and respiratory disorder experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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.Please note that this is the initial/final report for this product.

Event Description

As reported in the legal brief, a patient was treated with an optease vena cava filter.The filter subsequently malfunctioned and caused injury, including, but not limited to shortness of breath, sleep apnea, schronich coughing and general respiratory issues.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava, blood clots, discomfort and mental anguish.The form states there was an unsuccessful removal which left the device in place; however, the form also states that there has been no attempt to remove the device.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b4, b7, g3, g4, g7, h1 and h2.Section b5: additional information received per the physical therapy re-evaluation medical records indicate that the patient has a history of severe anemia and gastrointestinal bleeding.The patient was experiencing edema.The pt evaluation was done three days before implantation of the filter.As reported, a patient was treated with an optease inferior vena cava (ivc) filter.Per the medical records, history includes severe anemia, gastrointestinal bleeding and edema.The filter subsequently malfunctioned and caused injury, including, but not limited to shortness of breath, sleep apnea, coughing and general respiratory issues.Per the patient profile form (ppf), the patient experienced perforation of filter struts outside the inferior vena cava, blood clots, discomfort and mental anguish.The form states there was an unsuccessful removal which left the device in place; however, the form also states that there has been no attempt to remove the device.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.Anxiety, pain, sleep apnea, coughing and respiratory issues do 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.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.

Manufacturer Narrative

The patient was seen in the emergency room for complaints of muscles spasm to bilateral legs, unsteady gait and blood in the stool.The patient was noted to have a history of thiamin and b12 deficiency, bipolar disorder, chronic deep vein thrombosis (dvt), spinal stenosis, and knee knee surgery.Primary diagnosis on admission was severe anemia, pancytopenia, paraparesis and loss of balance.Prior to the filter implant, a triple lumen catheter was inserted via the right internal jugular vein.During the hospitalization the patient was diagnosed with a right lower extremity dvt, acute versus chronic renal failure and a urinary tract infection.The patient was scheduled to placement of an ivc filter, but the procedure was cancelled, as it was determined that the patient already had a cordis ivc filter in place.The medical records indicate that the ivc filter was most likely placed in another facility in for dvt prophylaxis, however there is not documentation to confirm prior placement of an ivc filter.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 9199843
• MDR Text Key: 166754785
• Report Number: 1016427-2019-03418
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 10/09/2019; 10/22/2019
• Supplement Dates FDA Received: 11/06/2019; 11/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR