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

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Embolus (1830); Occlusion (1984); Swelling (2091); Thrombosis (2100); Perforation of Vessels (2135)

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

The exact event date is not known.The exact catalog and lot numbers are not known.As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to filter perforation of the inferior vena cava (ivc), filter tilt and embedment, complex removal, and deep vein thrombosis (dvt).The filter remains implanted; thus, unavailable for analysis.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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Blood clots, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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 department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to: filter perforation of the inferior vena cava (ivc), filter tilt and embedment, complex removal, and deep vein thrombosis (dvt).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 continue to suffer significate medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

Section b5: the filter was deployed via the patient's right basilic vein with ultrasound guidance.It was placed below the level of the renal veins.A follow up scan demonstrated excellent positioning of the filter and no evidence of vessel injury.Additional information received per the patient profile form (ppf) states that the patient experienced filter perforation of the inferior vena cava (ivc), filter tilt, embedment, blood clots, clotting and or occlusion of the inferior vena cava.The patient became aware of the reported events approximately four years and four months after the index procedure when a removal procedure was performed.The form also states that the patient experienced pain and swelling.The patient states that due to swelling and pain, their left leg fells like lead and they are unable to perform daily duties.The patient lives with fear related to the filter.As reported, the patient underwent placement of the optease inferior vena cava (ivc) filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation of the inferior vena cava (ivc), tilt and embedment, complex removal, and deep vein thrombosis (dvt).Information provided by the patient indicated that the patient experienced blood clots, clotting and or occlusion of the inferior vena cava.The patient became aware of the reported events approximately four years and four months after the filter implant, when a removal procedure was performed, details of the removal procedure were not provided.The patient also reported experiencing pain and swelling and that due to the swelling and pain, the left leg feels like lead and they are unable to perform daily duties.The patient lives with fear related to the filter.The indication for the filter placement has not been provided, it is noted that a percutaneous intravenous central catheter was also placed during the filter implant procedure.The filter was placed via the right basilic vein and deployed below the level of the renal veins.A follow up scan demonstrated excellent positioning of the filter and no evidence of vessel injury.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.Without images for review, the reported tilt could not be confirmed.The timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the vessel anatomy, specifically asymmetry and tortuousity.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural explant details for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implant.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant problems in as short a period as 12 days.Blood clots, clotting and/or occlusion within the filter or the vasculature and dvt do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Leg pain, swelling and fear do not represent a device malfunction and may be related to underlying patient specific issues.Review of the limited information does not 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.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8867612
• MDR Text Key: 153840181
• Report Number: 1016427-2019-03132
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 BENSON WIRE; UNKNOWN 6 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 30 YR