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

Catalog Number 466F220A

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

Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Edema (1820); Embolus (1830); Occlusion (1984)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.As reported, the patient had an optease inferior vena cava (ivc) implanted.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pulmonary embolism, cardiac arrhythmias post ivc filter implant resulting in two week hospitalization, and lower extremity edema.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.No additional information is available.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior vena cava (ivc) 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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Without medical records available for review, a clinical conclusion could not be determined as to the cause of the cardiac arrhythmias and leg swelling reported.There are possible patient and pharmacological factors that may have contributed to the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient had an optease inferior vena cava (ivc) implanted.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pulmonary embolism, cardiac arrhythmias post ivc filter implant resulting in two week hospitalization, and lower extremity edema.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.No additional information is available.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient had an optease inferior vena cava (ivc) filter implanted.Per the medical records, the patient has a history of abdominal surgery for perforated viscus, pulmonary embolism (pe) with residual clot in the right popliteal vein and right heart strain.The filter was placed to prevent further pe due to the limited cardiac reserve.During the filter placement procedure, the filter was deployed over the l3 level without any complications.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, pe, cardiac arrhythmias post ivc filter implant resulting in two week hospitalization, and lower extremity edema.Per the patient profile form (ppf), the patient became aware of the alleged events two years and ten months post implantation.The patient reports blood clots, clotting and occlusion of the ivc and that the filter is unable to be retrieved.However, there have been no known attempts made to remove the filter.The patient also reports to be suffering from stress and anxiety.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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.Blood clots, pe and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Cardiac arrhythmia does not represent a device malfunction and may be related to underlying patient related issues.Swelling of the lower extremities does not represent a device malfunction and may be related to underlying patient related issues.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.

Manufacturer Narrative

The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the alleged events two years and ten months post implantation.The patient reports to have blood clots, clotting and occlusion of the ivc and that the filter is unable to be retrieved.However, there have been no known attempts made to remove the filter.The patient also reports to be suffering from stress and anxiety.According to the information received in the medical records, the patient has a history of abdominal surgery for perforated viscus, pe with residual clot in the right popliteal vein and right heart strain.The filter was placed to prevent further pe due to the limited cardiac reserve.During the filter placement procedure, the filter was deployed over the l3 level without any complications.The patient tolerated the procedure well.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary ; EI
• MDR Report Key: 7213462
• MDR Text Key: 98044266
• Report Number: 1016427-2018-01086
• 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,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/26/2017
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 81 YR