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

Model Number	466F220A
Health Effect - Clinical Codes	Coagulation Disorder (1779); Obstruction/Occlusion (2422)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient reported having an optease filter placed several years ago and being on blood thinners and having nothing but problems ever since.The patient mentioned that they were aware the filter has been recalled twice and that they cannot get it out unless they do open-chest surgery, which patient does not want to do and that they were having more and more problems after getting this thing.The patient subsequently reported becoming aware of blood clots, clotting and occlusion of the inferior vena cava (ivc), approximately nine years and ten months post implant.The patient also reported anxiety due to the filter.According to the implant record the indication for the filter implant was right lower extremity deep vein thrombosis (dvt), despite anticoagulation.The filter was place via the right common femoral vein and deployed in the infrarenal location without difficulty.The patient tolerated the procedure well and there were no immediate complications.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.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.Anxiety also does not represent a device malfunction and may be related to underlying patient specific issues.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, patient had an optease filter placed in the vena cava several years ago and patient has been on blood thinners ever since and having nothing but problems ever since.The patient mentioned that they were aware the filter has been recalled twice and that they cannot get it out unless they do open-chest surgery, which the patient does not want to do and that they were having "more and more problems after getting this thing".Per the implant records, the filter was indicated for recurrent right lower extremity deep venous thrombosis (dvt) despite anticoagulation.The right common femoral vein was accessed using micropuncture seldinger technique.An inferior venacavagram revealed a normal size inferior vena cava (ivc) with solitary bilateral renal veins.The device was placed into the infrarenal location without difficulty.Post procedure inferior venacavagram demonstrated excellent positioning.The patient tolerated the procedure well and there were no immediate complications.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting an occlusion of the ivc, becoming aware of these events approximately nine years and ten months after the filter implantation and further experienced anxiety related to the filter.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami laks FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 15141675
• Report Number: 1016427-2022-05415
• Device Sequence Number: 5557429
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K034050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R0408102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 08/01/2022
• Date Device Manufactured: 04/08/2008
• 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
• Patient Age: 54 YR
• Patient Sex: Male