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

Catalog Number 466FXXXX

Device Problem Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/13/2021

Event Type  Injury  

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 stenosis, caval thrombosis, perforation of organ and tilting.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.Blood clots, occlusive thrombosis of the filter and/or vasculature and stenosis 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.Ivc filter tilt has been associated with operator technique, vessel characteristics, 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 is unknown.Without images available for review the reported events could not be confirmed or 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

As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to stenosis, caval thrombosis, perforation of organ and tilting.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.

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 stenosis, caval thrombosis, perforation of organ and tilting.The patient reported becoming aware of perforation of filter struts outside the ivc, perforation of filter struts into organs, filter tilting, blood clots, clotting and occlusion of the ivc, approximately twelve years and ten months post implant.The patient also reports sharp pain in the abdomen, chest and arm and anxiety related to the filter.Per the implant records, the patient was reported to be status post trauma.The right common femoral vein was accessed with a needle, and a wire was directed in cephalic fashion to the superior aspect of the inferior vena cava (ivc).An inferior venacavography was performed demonstrating satisfactory caliber of the ivc and no indwelling clot.The optease ivc filter was deployed infrarenal.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.Blood clots, occlusive thrombosis of the filter and/or vasculature and stenosis 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.Ivc filter tilt has been associated with operator technique, vessel characteristics, 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 is unknown.Without images available for review the reported events 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, 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

As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to stenosis, caval thrombosis, perforation of organ and tilting.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.Per the implant records, the patient was reported to be status post trauma.The right common femoral vein was accessed with a needle, and a wire was directed in cephalic fashion to the superior aspect of the inferior vena cava (ivc).An inferior venacavography was performed demonstrating satisfactory caliber of the ivc and no indwelling clot.The optease ivc filter was deployed infrarenal.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, perforation of filter struts into organs, filter tilting, blood clots, clotting and occlusion of the ivc becoming aware of these events approximately twelve years and ten months after the filter implantation.The patient also reports sharp pain in the abdomen, chest and arm and further experienced anxiety related to the filter.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 12166428
• MDR Text Key: 261476127
• Report Number: 1016427-2021-05077
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 19-GAUGE NEEDLE, UNK 0.035 WIRE.; UNK SHEATH.; UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 37 YR