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	Perforation (2001); Stenosis (2263)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter perforation, tilting and stenosis.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 remains implanted and unavailable for analysis, 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.Stenosis is an abnormal narrowing of a vessel and does not represent a device malfunction.Clinical factors that may have influenced these events include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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 in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including but not limited to filter perforation, tilting and stenosis.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 suffer significant medical expenses, pain and suffering and other damages.
Event or Problem Description
Per the implant records, the patient was reported to have a history of lumbar disc disease, deep vein thrombosis (dvt), pulmonary embolism (pe) with ensuing pulmonary hypertension and was pending lumbar surgery.Filter placement was indicated in advance of surgery as the patient needed to be off anticoagulation for three weeks around the time of the lumbar surgery.The right femoral area was scanned briefly to ensure patency of the right femoral vein, and the area was then prepped with and draped in sterile fashion.Under direct ultrasound guidance, the right femoral vein was accessed with a needle.A guidewire was passed through the needle into the vena cava and proper position was confirmed fluoroscopically.The optease vena cava filter dilator and sheath were passed over the guidewire and guided into the proximal inferior vena cava (ivc) near the iliac vein junction.Power injection was done through a power injectable dilator.There was good opacification of the vena cava which measured approximately 2.25cm.The position of the right and left renal veins were noted.The left renal vein was noted considerably lower than the right.Next, the dilator was withdrawn, and the optease vena cava filter was introduced through the sheath to the tip of the sheath using the filter pusher.Under direct fluoroscopic guidance the filter was deployed such that its tip was positioned just beneath the lowest left renal vein.The filter deployed in excellent position.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports tilting of the filter, perforation of filter struts outside the ivc, and stenosis becoming aware of these events approximately ten years and eleven months after the filter implantation.The patient further experienced right leg pain and anxiety related to the filter.
Additional Manufacturer Narrative
As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter perforation, tilting and stenosis.The patient reported becoming aware of the events approximately ten years and eleven months post implant.The patient also reported right leg pain and anxiety related to the filter.According to the medical record the indication for the filter implant was a history of lumbar disc disease with impending surgery, deep vein thrombosis (dvt), and pulmonary embolism (pe) with ensuing pulmonary hypertension.The patient needed to be off anticoagulation for three weeks around the time of the lumbar surgery.The filter was placed via the right femoral vein and under direct fluoroscopic guidance the filter was deployed such that its tip was positioned just beneath the lowest left renal vein.The filter deployed in excellent position.The patient tolerated the procedure well.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.Stenosis is an abnormal narrowing of a vessel and does not represent a device malfunction.Clinical factors that may have influenced these events include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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.Leg pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues and 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.Section a3 (gender).

• Brand Name: OPTEASE RETRIEVAL FILTER
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 14595383
• Report Number: 9616099-2022-05673
• Device Sequence Number: 19347511
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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
• Device Lot Number: R0407458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2007
• 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 GUIDEWIRE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male