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

Catalog Number 466F220A

Device Problem Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of optease vena cava fitter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded to the wall of the inferior vena cava (ivc) and failed retrieval attempt.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

As reported, the patient underwent placement of optease vena cava fitter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded to the wall of the inferior vena cava (ivc) and failed retrieval attempt.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.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The optease 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 implantation date of the filter and the attempted retrieval date is unknown at this time.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.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.

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 patient has a history of deep vein thrombosis.The filter was deployed via the right common femoral vein.The filter was placed between the potential accessory left renal vein and the inferior vena cava bifurcation.A post deployment vena cavagram revealed that the placement was good.The patient tolerated the procedure well.Additional information received per the patient profile form (ppf) states that one month after the index procedure there was an attempt to remove the device.The filter was embedded into the walls of the inferior vena cava.Following the removal attempt, the patient experienced internal bleeding in her groin which required a blood transfusion.The filter remains implanted.The patient continues to experience worry and anxiety.Sex corrected to female.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Additional information received, the following sections have been updated accordingly.

Manufacturer Narrative

Event: 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, filter embedded to the wall of the inferior vena cava (ivc) and failed retrieval attempt.The patient also experienced bleeding in the groin after the removal attempt and continues to experience worry and anxiety.The indication for the filter implant was a history of deep vein thrombosis and a need for orthopedic surgery.The filter was placed via the right common femoral vein and deployed between what was thought to be a potential accessory left renal vein and the inferior vena cava bifurcation.The patient is reported to have tolerated the procedure well.Approximately one month later the patient underwent an unsuccessful percutaneous attempt to remove the filter.According to the information provided the filter was embedded and could not be retrieved.Following the removal attempt, the patient experienced internal bleeding in the groin which required a blood transfusion.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 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 procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Internal bleeding in the groin is a known potential procedural complication associated with percutaneous procedures, particularly post procedure when the access sheath is removed.Anxiety and 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.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
• MDR Report Key: 7143993
• MDR Text Key: 95724206
• Report Number: 1016427-2017-00895
• 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,Followup,Followup
• Report Date: 08/03/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/27/2017; 07/02/2018; 08/03/2018; 08/03/2018
• Supplement Dates FDA Received: 01/07/2018; 07/25/2018; 08/03/2018; 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SELDINGER NEEDLE; UNKNOWN 6-FRENCH SHEATH; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 51 YR