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

Model Number 466F220A

Device Problems Occlusion Within Device (1423); Failure to Align (2522)

Patient Problem Thrombosis (2100)

Event Date 03/13/2017

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 underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: clot in the filter, filter tilt, and failed attempted removal.As a direct and proximate result, 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, pain, and suffering, and other damages.No additional information is available.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.Without images, procedural films or medical records available for review, the reported events could not be confirmed and the exact cause could not be determined.Thrombosis within the ivc filter does not represent a device malfunction.Clinical factors that may have influenced this include patient, pharmacological, lesion characteristics or other comorbidities and not necessarily related to the implantation of the filter.Additionally, the timing and mechanism of the reported filter tilt is unknown.Patient, technique or procedural factors may have contributed to the reported tilt.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.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 underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: clot in the filter, filter tilt, and failed attempted removal.As a direct and proximate result, 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, pain, and suffering, and other damages.No additional information is available.

Manufacturer Narrative

(concomitant medical products) 5-french micropuncture system; j-wire; 8-french sheath accompanying the port-a-cath.(evaluation codes) 1779-clotting 1984 ¿ inferior vena caval occlusion the implant date was confirmed to be accurate.Complaint conclusion: it was reported that a patient underwent placement of an optease inferior vena cava (ivc) filter.The information provided indicated that the patient experienced tilt of the filter, blood clots, clotting and/or occlusion of the inferior vena cava (ivc) and that there was an unsuccessful retrieval attempt.According to the medical records the diagnosis at the time of implant was metastatic lung cancer, acute deep venous thrombosis and a hypercoagulable state (factor v leiden).The filter was placed via the right internal jugular vein and advanced until adequate ivc position was obtained.During the same procedure the patient had a port-a-cath placed through the same access site.Following inferior vena cava filter placement, plain fluoroscopy revealed good position of the ivc filter with mild tilt.The patient tolerated the procedure well with no complications.Approximately six months post implant, the patient underwent an unsuccessful percutaneous removal attempt.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 filters 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity, review of the information provided suggest that wither patient vessel characteristics or procedural factors may have contributed to the event.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 explant problems after as short a period as 12 days.Blood clots, clotting and or occlusion of the ivc do not represent a device malfunction.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 through the legal department via a legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: clot in the filter, filter tilt, and failed attempted removal.As a direct and proximate result, 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, pain, and suffering, and other damages.The following additional information was received per the patient¿s implant records: at the time of implant, the patient was diagnosed with acute deep vein thrombosis of left lower extremity, factor v leiden, and lower lobe lung cancer.The optease retrievable filter was oriented in internal jugular vein access position and advanced into the sheath until adequate inferior vena cava position was obtained.Following inferior vena cava filter placement, plain fluoroscopy revealed good position of the ivc filter with mild tilt.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), approximately six months post implantation, the patient underwent an unsuccessful percutaneous removal attempt.The patient reports tilt, blood clots, clotting, and/or occlusion of the ivc.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary 33152 ; EI 33152
• MDR Report Key: 7662642
• MDR Text Key: 113159056
• Report Number: 1016427-2018-01617
• 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
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 16004156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR