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

Model Number 466FXXXX

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

Patient Problem Myocardial Infarction (1969)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of a 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, heart attack.The information also indicated that as a direct and proximate result of this malfunction, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment and as a further and proximate result, the patient, has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.There is currently no additional information available.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.Myocardial infarction (mi), commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.Myocardial infarction does not indicate a device malfunction; rather, patient and pharmacological factors may have contributed to these events.With the limited information provided and no post implant imaging available for review the reported events could not be confirmed or further clarified, nor is it possible to establish a relationship between the reported event and the device.Given the limited information currently 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.

Event Description

As reported by the legal team, 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, heart attack.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, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.Additional information received per the medical records indicate that the filter was placed due to bilateral pulmonary embolism (pe) and deep vein thrombosis (dvt).The filter was placed via the right femoral vein and the filter was deployed at the level of the renal veins without complications.Additional information received per the patient profile form (ppf) states that the device is unable to be retrieved, the filter is in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.The patient became aware of the alleged failure approximately four years and five months after the index procedure.There have been no known attempts to remove the filter.The patient was reported to have also experienced fear of possible device failure in the future.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

As reported, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, heart attack.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, and pain and suffering, and other damages.Additional information received per the medical records indicate that the filter was placed due to bilateral pulmonary embolism (pe) and deep vein thrombosis (dvt).The filter was placed via the right femoral vein and the filter was deployed at the level of the renal veins without complications.Additional information received per the patient profile form (ppf) states that the device is unable to be retrieved, the filter is in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.The patient became aware of the alleged failure approximately four years and five months after the index procedure.There have been no known attempts to remove the filter.The patient was reported to have also experienced fear of possible device failure in the future.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.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, unease and worry.Myocardial infarction (mi), commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.Myocardial infarction does not indicate a device malfunction; rather, patient and pharmacological factors may have contributed to these events.With the limited information provided and no post implant imaging available for review the reported events could not be confirmed or further clarified, nor is it possible to establish a relationship between the reported event and the device.Given the limited information currently 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 CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7432540
• MDR Text Key: 105536545
• Report Number: 1016427-2018-01379
• 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: 07/17/2018

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 Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/19/2018
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 06/18/2018; 07/16/2018
• Supplement Dates FDA Received: 07/16/2018; 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening
• Patient Age: 60 YR