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

Model Number 466F220A

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Failure to Align (2522)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 11/09/2009

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.The catalog number is unknown, if received it will be provided.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by 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: filter perforating the vena cava with significant tilt.Failed filter removal due to tilt and thrombus in filter.As a direct and proximate result, patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result.Patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

Complaint conclusion: as reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: filter perforating the vena cava with significant tilt, failed filter removal due to tilt and thrombus in filter.The filter remains implanted; thus, unavailable for analysis.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.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.

Manufacturer Narrative

Corrected section d4: lot number.Additional information was provided and is available in: section h4 (manufacturing date) section h6 (evaluation codes) complaint conclusion: as reported, the patient had placement of optease inferior vena cava (ivc) filter.Per the medical records, the indication for filter placement was dvt/pe for back surgery and patient would have extended duration immobilization.The filter was deployed just below the level of the lowest renal vein.Satisfactory deployment was noted, and no complications were seen.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to failed filter removal due to tilt and thrombus in filter.Approximately 1 month and 2 weeks post implantation, patient underwent an attempted removal of the filter.The filter still could not be retrieved.The attempted removal of the filter resulted in deforming of the filter and a small amount of thrombus forming on the inferior tip of the filter.The filter was not be able to be removed and the patient resumed anticoagulation following the procedure.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved.The patient also reports suffering from anxiety.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.Altered shape of the device is a known potential event associated with use of the ivc filters, the ivc is a dynamic vessel subject to ongoing physical stressed and this and impact the shape of the filter struts over time.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.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.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 has been shown to lead to explantation problems after as short a period as 12 days.Blood clots, thrombosis and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by 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: failed filter removal due to tilt and thrombus in filter.As a direct and proximate result, patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result.Patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The following additional information was received per the patient¿s medical records: the indication for filter placement was dvt/pe for back surgery and patient would have extended duration immobilization.The filter was deployed just below the level of the lowest renal vein.Satisfactory deployment was noted by single spot fluoroscopic image.The patient tolerated the procedure well, and no immediate complications were seen.Approximately 1 month and 2 weeks post implantation, patient underwent an attempted removal of the filter.After 86 minutes of fluoroscopy time was utilized, the filter still could not be retrieved.The procedure was discontinued, and sheath was withdrawn and direct pressure was held and hemostasis was achieved.Attempted removal of the filter resulted in deforming of the filter and a small amount of thrombus forming on the inferior tip of the filter.The filter was not be able to be removed and the patient resumed anticoagulation following the procedure.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 1 month and 2 weeks post implantation.The patient reports blood clots, clotting, and/or occlusion of the ivc, and device unable to be retrieved.Approximately 1 month 2 weeks post implantation, an attempted but unsuccessful percutaneous removal procedure.The patient also reports suffering from anxiety.

Manufacturer Narrative

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

• Brand Name: 466F220A
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8114017
• MDR Text Key: 128715400
• Report Number: 1016427-2018-02330
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1108035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR