MAUDE Adverse Event Report: CORDIS CASHEL 466F220A; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F220A

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2017

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 optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to pain, an attempted, unsuccessful percutaneous removal, embedding, and an inability to be safely removed.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 by the legal brief, the patient underwent placement optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to pain, an attempted, unsuccessful percutaneous removal, embedding, and an inability to be safely removed.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.Pain does not represent a device malfunction.Such an event may be related to other comorbidities and not necessarily related to the implantation of the filter.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

Gtin # (b)(4).

Event Description

As reported by the legal brief, the patient underwent placement optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to pain, an attempted, unsuccessful percutaneous removal, embedding, and an inability to be safely removed.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.According to the medical records received on 03/07/2018: the patient underwent a successful inferior vena cava (ivc) filter placement without difficulty for patient inability to anti coagulate despite thrombosis.The inferior vena cava filter was placed without difficulty.The optease was placed through a 6 french sheath at the level of the l2 after identification of renal veins.Retrograde percutaneous access was performed through the left femoral vein.Approximately five days later the patient underwent an unsuccessful inferior vena cava (ivc) filter retrieval due to fibrosis.The arterial access site was prepped and draped sterilely.Local anesthesia was administered.The sheath was then inserted using the seldinger technique.Retrograde percutaneous access was performed through the right femoral artery.A 4 french sheath was inserted and was exchanged for an 8 french sheath.The retrieval hook is embedded in the inferior vena cava (ivc) and could not be moved for retrieval as it could not be engaged nor pushed to have more access for capture.The case was aborted.

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 pain, an attempted, unsuccessful percutaneous removal, embedding, and an inability to be safely removed.The location of the reported pain has not been provided.The patient has a history of pulmonary embolism (pe) and deep vain thrombosis (dvt).The device was implanted emergently due to thrombosis and inability to anticoagulated.The reason for not being able to anticoagulated has not been provided.The filter was placed via the left common femoral vein at the level of l2.The filter was placed without difficulty.Approximately two months later the patient underwent an unsuccessful percutaneous removal attempt of the filter.The retrieval attempt was due to fibrosis.The retrieval attempt access site was the right common femoral vein.Attempts to capture the filter were unsuccessful given that the hook of the filter was embedded in the inferior vena cava (ivc), the hook could not be engaged nor pushed to have more access for capture, as such the case was aborted.There is currently no additional information available.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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 notes or imaging available and the limited information available it is not possible to determine what factors may have contributed to the filter being embedded.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.Pain does not represent a device malfunction and may be related to patient specific underlying issues.Given the limited information currently available for review, 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: 466F220A
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7146305
• MDR Text Key: 95770193
• Report Number: 1016427-2017-00912
• 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,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• 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
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTRAST MATERIAL -VISIPAQUE 30ML
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 123