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

Catalog Number 466FXXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Embolus (1830); Occlusion (1984); Perforation of Vessels (2135)

Event Date 08/08/2016

Event Type  Death  

Manufacturer Narrative

As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of deep vein thrombosis, pulmonary emboli and gastrointestinal bleeding when on anticoagulation therapy.The patient also had severe degenerative changes across the l5-s1 level with bilateral pars defects, significant neural foraminal stenosis bilaterally and shortness of breath.The medical records also state that the patient had a history of right leg edema, occlusive deep vein thrombosis in the right femoral, popliteal and posterior tibial veins.The filter was deployed via the right common femoral vein, in the infrarenal area.The patient tolerated the procedure well.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to pulmonary embolism and death.Per the patient profile form (ppf), the patient experienced perforation of the filter strut(s) outside of the inferior vena cava, blood clots, clotting and occlusion of the inferior vena cava.The form states that the device was unable to be retrieved and there was never an attempt to remove the filter.Approximately one year after the index procedure, the patient died.The certificate of death states that the cause of death was pulmonary embolus.Contributing factors were listed as gastrointestinal bleeding, sepsis and diabetes.The filter is 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.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.Blood clots, post procedure pulmonary embolism leading to death, 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.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 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 pulmonary embolism and death.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of the filter strut(s) outside of the inferior vena cava, blood clots, clotting and occlusion of the inferior vena cava.The form states that the device was unable to be retrieved and there was never an attempt to remove the filter.Information received per the medical records indicate that the patient has a history of deep vein thrombosis, pulmonary emboli and gastrointestinal bleeding when on anticoagulation therapy.The patient also had severe degenerative changes across the l5-s1 level with bilateral pars defects, significant neural foraminal stenosis bilaterally and shortness of breath.The medical records also state that the patient had a history of right leg edema, occlusive deep vein thrombosis in the right femoral, popliteal and posterior tibial veins.The filter was deployed via the right common femoral vein.It was placed in the infrarenal area.The patient tolerated the procedure well.Approximately one year after the index procedure the patient died.The certificate of death states that the cause of death was pulmonary embolus.Contributing factors were listed as gastrointestinal bleeding, sepsis and diabetes.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8122607
• MDR Text Key: 129013367
• Report Number: 1016427-2018-02339
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR