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

Model Number	466F220A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 tilt of the inferior vena cava (ivc) 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 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 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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Without images available for review the reported event 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.Please note that this is the initial report for this product.
Event or Problem Description
As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to tilt of the inferior vena cava (ivc) filter.As a direct and proximate result of these malfunctions, 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
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 tilt of the inferior vena cava (ivc) filter.The patient reported becoming aware of the event approximately eight years and nine months post implant.The patient reported that mental and physical pain related to the tilted filter.The indication for the filter placement and procedural details were not provided.The filter was placed via the right femoral vein, according to the procedure log.Approximately eight years and nine months post implant an abdominal computed tomography (ct) scan was done to evaluate the filter.Results of the scan noted an approximate 20¿30-degree anterior tilt of the upper portion with the apex abutting the ivc wall.The filter is positioned such that the filter apex is located inferior to the renal veins, 1.6 cm inferior to the lower right renal vein.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 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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Without images available for review the reported event could not be confirmed or further clarified.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues and 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.
Event or Problem Description
The filter was implanted via the patient's right femoral vein.Approximately eight years and nine months after the index procedure an abdominal computed tomography (ct) scan was done to evaluate the inferior vena cava (ivc) for an unspecified injury.The images revealed: an approximately 20-30 degree anterior tilt of the upper portion with the apex abutting the ivc wall.The filter is positioned such that the filter apex is located inferior to the renal veins, 1.6 cm inferior to the lower right renal vein.There appears to be a calcified right basilar granuloma and the aorta is atherosclerotic.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt.The patient became aware of the reported event approximately eight years and nine months after the index procedure.The patient reported that they also experienced mental and physical pain related to the tilted filter.

• 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: 14179474
• Report Number: 9616099-2022-05568
• Device Sequence Number: 5025624
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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 Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 0.035 BENTSON WIRE.; UNKNOWN 0.035 GUIDE WIRE.; UNKNOWN 5 FRENCH MICROPUNCTURE.; UNKNOWN CATHETER.; UNKNOWN SHEATH.; UNKNOWN.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White