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

Catalog Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problem Perforation of Vessels (2135)

Event Date 07/25/2013

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.

Event Description

As reported by the legal department, the plaintiff underwent a surgical procedure to implant an optease filter for the treatment of a left femoral deep vein thrombosis.The device in the patient was positively identified on medical records.As of the present, the patient is still implanted with the optease filter, which is known to be dangerous and cause serious side effects.As the result of the optease filter installation, the patient suffered and will be at risk of suffering from future injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses.Additional information received per the medical records indicate that the patient has a history of left femoral deep vein thrombosis, hypertension, vascular disease, internal hemorrhoids, neurological disease, migraine headaches, pulmonary disease, coronary arteriosclerosis, chest pain shortness of breath, and asthma.The patient also has a history of anxiety and depression, the patient was under outpatient treatment.The filter was deployed via the right common femoral vein.It was placed in the infrarenal area of the inferior vena cava.The results of computed tomography (ct) scans done approximately four years and one month after the index procedure indicate that the filter is located below the level of the renal veins.The ct scan revealed that the superior hook of the filter was tilted 15 degrees anteriorly within the vessel.The superior pole rests against the mid anterior wall.The struts protrude minimally beyond the border of the inferior vena cava.There was no evidence of fracture in the struts.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the ivc, tilting of the filter, pain, suffering and fear.

Event Description

As reported by the legal department, the plaintiff underwent a surgical procedure to implant an optease filter for the treatment of a left femoral deep vein thrombosis.The device in the patient was positively identified on medical records.As of the present, the patient is still implanted with the optease filter, which is known to be dangerous and cause serious side effects.As the result of the optease filter installation, the patient suffered and will be at risk of suffering from future injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses.Additional information received per the medical records indicate that the patient has a history of left femoral deep vein thrombosis, hypertension, vascular disease, internal hemorrhoids, neurological disease, migraine headaches, pulmonary disease, coronary arteriosclerosis, chest pain shortness of breath, and asthma.The patient also has a history of anxiety and depression, the patient was under outpatient treatment.  the filter was deployed via the right common femoral vein.It was placed in the infrarenal area of the inferior vena cava.The results of computed tomography (ct) scans done approximately four years and one month after the index procedure indicate that the filter is located below the level of the renal veins.The ct scan revealed that the superior hook of the filter was tilted 15 degrees anteriorly within the vessel.The superior pole rests against the mid anterior wall.The struts protrude minimally beyond the border of the inferior vena cava.There was no evidence of fracture in the struts.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the ivc, tilting of the filter, pain, suffering and fear.

Manufacturer Narrative

Initial reporter occupation: other, senior counsel, litigation.

Manufacturer Narrative

As reported, the patient had implant of an optease inferior vena cava (ivc) filter for the treatment of a left femoral deep vein thrombosis.Per the medical records, the patient has a history of left femoral deep vein thrombosis, hypertension, vascular disease, internal hemorrhoids, neurological disease, migraine headaches, pulmonary disease, coronary arteriosclerosis, chest pain shortness of breath, and asthma.The patient also has a history of anxiety and depression, the patient was under outpatient treatment.The filter was deployed via the right common femoral vein.It was placed in the infrarenal area of the inferior vena cava.The patient is still implanted with the optease filter, which is known to be dangerous and cause serious side effects.A ct scan done approximately four years and one month after the index procedure indicates that the filter is located below the level of the renal veins.The ct scan revealed that the superior hook of the filter was tilted 15 degrees anteriorly within the vessel.The superior pole rests against the mid anterior wall.The struts protrude minimally beyond the border of the inferior vena cava.There was no evidence of fracture in the struts.Per the patient profile form (ppf), the patient reports perforation of filter strut(s) outside the ivc, tilting of the filter, pain, suffering and fear.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.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.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; cashel ; EI
• MDR Report Key: 8200882
• MDR Text Key: 138965693
• Report Number: 1016427-2018-02370
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K023116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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: 01/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR
• Patient Weight: 111