MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problems Obstruction of Flow (2423); Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Calcium Deposits/Calcification (1758); Scarring (2061); Perforation of Vessels (2135)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

As reported, a patient underwent placement of an optease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, filter tilt, perforation of the filter outside the inferior vena cava (ivc) wall and embedment of the device.The patient further reported that the device could not be retrieved; though an attempt to retrieve the filter was not documented.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.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 ivc 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 or procedural films for review, the reported filter tilt, ivc perforation and device embedment events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.The predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.The optease vena cava filter is indicated for retrieval up to 23 days post-implantation.Following this period of time, and as early as twelve days, there is potential for endothelialization around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 team, the filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: tilt of the ivc filter perforation of filter struts outside the ivc wall, embedment of the iv filter and device is unable to be retrieved.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, and pain and suffering, and other damages.

Manufacturer Narrative

Concomitant devices: unk guidewire, unk 4f catheter.Complaint conclusion: as reported, the cordis optease ivc (inferior vena cava) filter malfunctioned and caused injury, damage, to the patient, including, but not limited to: tilt of the ivc filter perforation of filter struts outside the ivc wall, embedment of the iv filter and device is unable to be retrieved.Per the medical records, history includes bilateral pulmonary embolism (pe) and bilateral lower extremity deep vein thrombosis (dvt).At the time of the procedure, the patient had both dvt and pe while not on coumadin.The filter was deployed below the renal vein infrarenal inferior vena cava in a satisfactory position.The patient tolerated the procedure well.Approximately four years post implant, a ct scan revealed mild dependent atelectasis and or scarring at the lung bases and vascular calcification visualized thoracic aorta.The ivc filter is oriented parallel to the long axis of the ivc.There is some ivc tilt such that the upper aspect of the filter abuts the anterior wall of the ivc.The apex of the filter is below the level of the renal veins.No acute fracture of any strut was seen.While the edges of the ivc filter have the appearance of extending slightly beyond the lumen of the ivc especially medially, there is no clear fat plane between these portions of the filter in the ivc.No fluid or stranding surrounding the ivc.Other findings include mild hepatomegaly with fatty infiltration of the liver, chronic diverticulosis without evidence of acute diverticulitis, status post cholecystectomy, the common duct mildly dilated although this might be related to post cholecystectomy state and a small hiatal hernia.Per the patient profile form (ppf), the patient reports ivc filter tilt, filter embedded in wall of the ivc, perforation strut, in addition to device unable to be retrieved; however, retrieval attempt information details or documentation were not provided.The patient further reports being upset the filter was placed in error and the filter was unable to be removed ten days later.The patient has extreme anxiety and fear.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Aortic calcification and lung scarring, while not specifically listed in the device ifu, are know events associated to the use of the ivc filter device.In this case, the aortic calcification may be related to the perforation of the struts impacting the wall of the aorta, and the lung scarring may be from the known events of pulmonary embolism in the patient history.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.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 team, the filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: tilt of the ivc filter perforation of filter struts outside the ivc wall, embedment of the iv filter and device is unable to be retrieved.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, and pain and suffering, and other damages.The following additional information was received per the patient¿s implant records, the patient had a medical history of bilateral pulmonary embolism (pe) and bilateral lower extremity deep vein thrombosis (dvt).At the time of the procedure, the patient was suffering from both dvt and pe and was not on coumadin.The physicians recommended the optease inferior vena cava (ivc) filter be inserted through the right internal jugular vein, in case the patient could not take anticoagulation.The filter was inserted and discharged below the renal vein infrarenal inferior vena cava in satisfactory position.The patient tolerated the procedure well.According to the medical records provided, about four years and twenty-three days post implantation, the ivc filter was evaluated by a computed tomography (ct) of the abdomen without contrast.The ct revealed mild dependent atelectasis and or scarring at the lung bases and vascular calcification visualized thoracic aorta.The ivc filter is oriented parallel to the long axis of the ivc.There is some ivc tilt such that the upper aspect of the filter abuts the anterior wall of the ivc.The apex of the filter is below the level of the renal veins.No acute fracture of any strut was seen.While the edges of the ivc filter have the appearance of extending slightly beyond the lumen of the ivc especially medially, there is no clear fat plane between these portions of the filter in the ivc.No fluid or stranding surrounding the ivc.Other findings include mild hepatomegaly with fatty infiltration of the liver, chronic diverticulosis without evidence of acute diverticulitis, status post cholecystectomy, the common duct mildly dilated although this might be related to post cholecystectomy state and a small hiatal hernia.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately eleven days post implantation.The patient reports ivc filter tilt, filter embedded in wall of the ivc, perforation strut, in addition to device unable to be retrieved; however, retrieval attempt information details or documentation were not provided.The patient also reports psychological injuries or mental anguish from being afraid the filter will break up in the stomach as the filter is full of clots and there is no more room for anymore.The patient further reports being upset the filter was placed in error.The filter was unable to be removed ten days later, which has caused the patient extreme fear of having an unnecessary filter in the body with such extreme problems with blood clots in the patient¿s body.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 8666426
• MDR Text Key: 146918705
• Report Number: 1016427-2019-02928
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: 17031042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR