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

Model Number	466FXXXX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Coagulation Disorder (1779); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
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, thrombosed filter requiring suction thrombectomy of the ivc and complex forceps retrieval 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.
Additional Manufacturer Narrative
The catalog number is unknown.If received it will be provided.It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused a thrombosed filter requiring suction thrombectomy of the ivc and complex forceps retrieval of the filter.The indication for the filter implant, procedural details and medical history of the patient have not been provided.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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.Thrombosis was reported, due to the nature of the complaint the event could not be further clarified.Blood clots, clotting and occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Without images available for review the reported event could not be confirmed or further clarified.Given the limited information available for review, there is nothing to suggest that a malfunction in 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.
Additional Manufacturer Narrative
It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused a thrombosed filter requiring suction thrombectomy of the inferior vena cava (ivc) and complex forceps retrieval of the filter.The patient reported becoming aware of blood clots, clotting, and occlusion of the ivc, approximately fourteen years and five months post implant.The patient sustained a thrombosed ivc and ivc filter which required suction thrombectomy, and successful percutaneous retrieval of the filter about fourteen years and six months post implant.The patient is in possession of the explanted device.According to the medical record the patient had a history of multiple back surgeries and was requiring a staged procedure to stabilize the lower spine.The filter was indicted prophylactically due to major orthopedic surgery.The filter was placed via the right femoral vein and was positioned and deployed at the l2-l3.The patient tolerated this portion of the procedure well and was then prepared for the orthopedic procedure.Approximately fourteen years and six months post implant, the patient presented for ivc filter removal.The medical history at the time was notable for right jaw dissection for oral squamous cell carcinoma and status post left nephrectomy for renal cell carcinoma, and deep vein thrombosis (dvt) in the setting of holding eliquis for multiple spinal surgeries, now found to have thrombus on top of the ivc.The patient presented for ivc removal after recovering from cancer surgeries that prohibited the use of anticoagulation.Access was made at the right internal jugular vein and the right common femoral vein.A diagnostic venogram confirmed the presence of thrombus in the ivc.Suction thrombectomy superior to the filter was performed followed by successful removal of the filter with forceps.The patient tolerated the procedure well with no complications.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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 do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.It is unknown if the patient was on anticoagulation at the time of the deep vein thrombosis and observation of ivc thrombus.Given the limited information available for review, there is nothing to suggest that a malfunction in 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
Per the implant records, the patient was reported to have a history of multiple back surgeries and was requiring a staged procedure to stabilize the lower spine.The filter was indicted prophylactically due to major orthopedic surgery.The right groin was prepped and draped in the usual manner.The femoral vein was identified and entered with an entry needle, and a wire was placed.An inferior venacavogram was performed, and the optease filter, was positioned and deployed at the l2-l3.The patient tolerated this portion of the procedure well and was then prepared for the orthopedic procedure.About fourteen years and six months after the filter was implanted, the patient presented for ivc filter removal.The medical history at the time is notable for right jaw oral squamous cell carcinoma (scc) status post dissection (about nine years post implant) renal cell carcinoma (rcc) status post left nephrectomy, and deep vein thrombosis (dvt) in setting of holding eliquis for multiple spinal surgeries status post ivc filter now found to have thrombus on top of the ivc.The patient had been required to be on pulmonary embolism (pe) prophylaxis during multiple surgeries for cancer due to the inability to be anticoagulated.The patient had since recovered from all these surgeries and presented for ivc removal.Ultrasound guided access of the right internal jugular (rij) vein and of the right common femoral vein (cfv) was obtained; a diagnostic venogram confirmed the presence of thrombus in the ivc.Suction ivc thrombectomy superior to the filter was then performed followed by successful removal of the filter with forceps.The patient tolerated the procedure well with no complications.According to the information received in the patient profile form (ppf), the patient reported blood clots, clotting, and occlusion of the ivc, becoming aware of these events approximately fourteen years and five months after the filter implantation.The patient further asserts to have suffered from physical pain post implant and sustained a thrombosed ivc and ivc filter which required suction thrombectomy, and successful percutaneous retrieval of the filter about fourteen years and six months after the filter was implanted.It was additionally noted that the patient is in possession of the explanted device.
Additional Manufacturer Narrative
Device manufacture and expiration dates provided.Refer to sections d4 and h4.

• 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: 15391566
• Report Number: 9616099-2022-05955
• Device Sequence Number: 20085302
• 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: K034050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2022

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 Expiration Date: 04/30/2009
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: R0506538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 10/07/2022; 10/07/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/31/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2006
• 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: UNK NEEDLE, UNK BENTSON WIRE
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male