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

Catalog Number 466FXXXX

Device Problem Unintended Movement (3026)

Patient Problems Perforation (2001); Perforation of Vessels (2135); Stenosis (2263); Anxiety (2328); Depression (2361)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Reporter 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 filter perforation, tilt and inferior vena cava (ivc) stenosis.The indication for the filter placement was not 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 practitioner technique and/or 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 tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.Stenosis is an abnormal narrowing in a blood vessel and does not represent a device malfunction.With the limited information provided the 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.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 perforation, tilt and inferior vena cava (ivc) stenosis.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.

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 filter perforation, tilt and inferior vena cava (ivc) stenosis.The patient reported becoming aware of the events approximately seven years and eleven months post implant.The patient also reported anxiety related to the filter and taking medication for depression.According to the implant records, the patient presented chest pain, shortness of breath and gastrointestinal (gi) bleeding.An endoscopy found duodenal ulcers that were not actively bleeding.A computed tomography angiography (cta) demonstrated a large right pulmonary embolus.No lower extremity clots were found on ultrasound.The filter was indicated in lieu of anticoagulation.The filter was placed via the right common femoral vein and deployed with the tip at level of the l1-l2 interspace.The filter was centrally deployed and normally oriented.There were no complications.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 practitioner technique and/or 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 tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.Stenosis is an abnormal narrowing in a blood vessel and does not represent a device malfunction.With the limited information provided the events could not be confirmed or further clarified.Anxiety and depression do not represent a device malfunction and may be related to underlying patient specific issues.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.People with depression often experience symptoms similar to those of an anxiety disorder.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 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 perforation, tilt and inferior vena cava (ivc) stenosis.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.Per the implant records, prior to the index procedure the patient was admitted with a history of right chest pain, shortness of breath and gastrointestinal (gi) bleeding.The patient was intubated on admission, and by esophagogastroduodenoscopy (egd) was found to have duodenal ulcers which were not actively bleeding; a large right pulmonary embolus (pe) was demonstrated by computed tomography angiography (cta).A duplex found no clots in the lower extremities.The filter was indicated in lieu of anticoagulation while the patient remined intubated and sedated.Under sterile conditions and using ultrasound imaging, the right common femoral vein was accessed with a hemostasis sheath.An inferior venacavogram revealed a normally patent inferior vena cava and the renal veins at the l1-l2 interspace.Additionally, selective right and selective left renal venograms were completed.A removable (optease) inferior vena cava filter was placed with its tip at the l1-l2 interspace.The filter was centrally deployed and normally oriented.There were no complications.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, tilting and stenosis becoming aware of these events approximately seven years and eleven months after the filter implantation.The patient further experienced worry and anxiety related to the filter and currently takes medication for depression.

• 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: 11222931
• MDR Text Key: 228442809
• Report Number: 1016427-2021-04726
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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: 02/10/2021
• Patient Sequence Number: 1
• Treatment: UNK 6F SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR