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

Model Number	466FXXXX
Medical Device Problem Codes	Failure to Align (2522); Unintended Movement (3026)
Health Effect - Clinical Codes	Coagulation Disorder (1779); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The catalog number and lot number are unknown; if received it will be provided.Complaint conclusion: as reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt and embedment of the filter.The indication for the filter implant, procedural details and medical history of the patient have not been provided and there is currently no additional information available for review.The product is not available 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 reported ¿filter embedded and erosion through the iliac vein¿, could not be confirmed or further clarified at this time.The optease vena cava filter is indicated 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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.The timing and mechanism of the events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.Without images available for review the reported events could not be confirmed or further clarified.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 or Problem Description
As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, tilt and embedment of the filter.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.
Event or Problem Description
Additional information received per the medical records state that the indication for filter placement was deep vein thrombosis (dvt) and bilateral pulmonary embolism (pe).The filter was implanted via the patient's right groin.Additional information received per the patient profile form (ppf) states that the patient experienced tilt, filter embedded in wall of inferior vena cava (ivc), blood clots, clotting and/or occlusion of the ivc.The patient became aware of the reported events approximately thirteen years and one or two months after the index procedure.The patient also experience difficulty breathing, chest pain while breathing quick breaths and shortness of breath.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilt and embedment of the filter.The patient reported becoming aware of tilt, filter embedded in wall of inferior vena cava (ivc), blood clots, clotting and/or occlusion of the ivc, approximately thirteen years and two months post implant.The patient reported shortness of breath and chest soreness with a quick exhale.According to the medical record the indication for the filter implant was deep vein thrombosis and bilateral pulmonary embolus.The filter was implanted via the right groin without ¿much problems¿.The product remains implanted and unavailable 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 optease vena cava filter is indicated 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.Blood clots, clotting and occlusive thrombosis within the filter and/or vasculature does not represent a device malfunction.Clinical factors that may have influenced the events include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.The timing and mechanism of the events has not been reported at this time.Without images available for review the reported events could not be confirmed or further clarified.Chest pain and shortness of breath do not represent a device malfunction and may be related to underlying patient specific issues or undisclosed comorbidities.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
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15415524
• Report Number: 9616099-2022-05973
• Device Sequence Number: 20487845
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2009
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: R0306323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LONG SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male