MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problem Unintended Movement (3026)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation date of event: 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 filter tilt and caval thrombosis.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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.Caval thrombosis was reported.Blood clots, occlusive thrombosis of the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and caval thrombosis could not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with operator technique, vessel characteristics, specifically asymmetry and tortuosity.Given the limited information currently available for review, 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/final report for this product.

Event 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 filter tilt and caval thrombosis.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, and pain and suffering, loss of enjoyment of life and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b6, b7, d10, g2, g3, g6, h1 and h2.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 filter tilt and caval thrombosis.The patient reported becoming aware of the events approximately ten years and six months post implant.The patient also reported experiencing pain and worry related to the filter.According to the medical records, the patient had a history of lower extremity deep vein thrombosis (dvt) despite anticoagulation therapy.Access was obtained in the left common femoral vein, due to scarring of the right common femoral vein, access could not be obtained there.A venogram of the left iliac system revealed chronic dvt with multiple collaterals.A soft glide wire was used to navigate to the vena cava.The filter was placed below the lowest renal vein.The postprocedural venogram showed good positioning of the device.The patient tolerated the procedure well.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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.Caval thrombosis was reported.Blood clots, occlusive thrombosis of the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and caval thrombosis could not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with operator technique, vessel characteristics, specifically asymmetry and tortuosity.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Given the nature of the complaint the events could not be further clarified.Given the limited information currently available for review, 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 Description

Additional information received per the medical records indicate that the patient has a history of lower extremity deep vein thrombosis (dvt) despite anticoagulation therapy.Initially, the patient's right common femoral vein was accessed.However, the vein was "quite scarred." the procedure was aborted.Next, the left common femoral vein was accessed.The venogram on the left iliac system revealed chronic dvt with multiple collaterals.A soft glide wire was used to navigate to the vena cava.The filter was placed below the lowest renal vein.The postprocedural venogram showed good positioning of the device.The patient tolerated the procedure well. additional information received per the patient profile form (ppf) states that the patient experienced filter tilt and caval thrombosis.The patient became aware of the reported events approximately ten years and six months after the index procedure.The patient also experienced pain and worry.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12333704
• MDR Text Key: 267093196
• Report Number: 1016427-2021-05293
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH SHEATH.; UNKNOWN MICROPUNCTURE WIRE.; UNKNOWN SOFT GLIDE WIRE.; UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR