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

Catalog Number 466FXXXX

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

Patient Problem Thrombosis (2100)

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 of optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, a post filter deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the patient has suffered life-threatening injuries and damages, and required extensive medical care and treatment.The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots.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 filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, a post filter deep vein thrombosis (dvt).As a direct and proximate result of these malfunctions, the patient has suffered life-threatening injuries and damages, and required extensive medical care and treatment.The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots.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 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for 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.

Manufacturer Narrative

Additional information provided on the patient profile form (ppf) alleged a device failure mode not specified, that it is too risky to attempt retrieval of the filter as it has been in place for more than ninety days.The patient is also reported to have fear of a possible device failure in the future.Information contained in the medical records indicated that the filter was placed due to left ilieofemoral deep vein thrombosis (dvt) and bilateral pulmonary embolism (pe).During the implant procedure large thrombus was noted in the ivc and in the left common iliac vein.Infrarenal filter was placed above the level of the thrombus.There were no immediate complications and the patient was transferred in stable condition.The plan was to bring the patient back the following day for thrombolysis of the clots in the ivc, left iliac and left femoral veins.The patient also indicates the first day she became aware of the events was (b)(6) but a year was not provided.Please note updates to section.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a patient underwent placement of 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, a post filter deep vein thrombosis (dvt).The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots.Additional information provided on the patient profile form (ppf) alleged a device failure mode not specified, that "it is too risky to attempt retrieval of the filter as it has been in place for more than ninety days." the patient is also reported to have fear of a possible device failure in the future.Information contained in the medical records indicated that the filter was placed due to left ileo-femoral deep vein thrombosis (dvt) and bilateral pulmonary embolism (pe).During the implant procedure large thrombus was noted in the ivc and in the left common iliac vein.The infrarenal filter was placed above the level of the thrombus.There were no immediate complications and the patient was transferred in stable condition.The plan was to bring the patient back the following day for thrombolysis of the clots in the ivc, left iliac and left femoral veins.There is currently no additional information available for review.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 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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).The ivc filter is not indicated for use in the prevention of deep vein thrombosis.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, there is nothing to suggest that there is an issue 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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7146083
• MDR Text Key: 95762535
• Report Number: 1016427-2017-00911
• 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
• Report Date: 07/11/2018

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 Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 12/27/2017; 06/04/2018; 07/07/2018
• Supplement Dates FDA Received: 01/05/2018; 07/03/2018; 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 70 YR