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

Catalog Number 466F220B

Device Problem Unintended Movement (3026)

Patient Problems Perforation (2001); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 01/19/2021

Event Type  Injury  

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 perforation, tilting and embedment.The indication for the filter implant, procedural details and medical history of the patient have not been 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.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implant.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, 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.Ivc filter tilt has been associated with operator technique and 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 events.Without images available for review the reported 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.

Event Description

As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to perforation, tilting and embedment.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 suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of deep vein thrombosis and a recent myocardial infarction (mi).The patient presented to hospital with a massive bilateral pulmonary embolism (pe).The patient was scheduled to undergo a cardiac procedure and placement of the inferior vena cava (ivc) filter was advised since patient¿s medical team felt that vena cava interruption was necessary for the patient's medical safety during the planned cardiac procedure.The patient initially underwent a diagnostic venography via the common femoral vein which demonstrated an abnormally large ivc, especially below the renal veins where the cava was greater in size.Therefore, an optease retrievable vena cava filter was placed in the lower lumbar aorta since this gave the greatest diameter relative to other filters and could be retrieved later.Post-procedural images revealed no evidence of evolving hematoma or filter migration.The patient was noted to be stable and asymptomatic except for chronic back pain that had been present for days.The patient is reported to have tolerated the procedure well.Approximately thirteen years after the filter implantation, the patient became aware that the filter had tilted, become embedded and filter struts had perforated outside the ivc.The patient further reported having experienced anxiety and edema from the waist down that was causing lower extremity pain associated with the filter.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 retrievable vena cava filter is indicated for use in the prevention of recurrent 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 retrievable 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.Due to the nature of the complaint, the reported edema experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.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.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 brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to perforation, tilting and embedment.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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a history of massive bilateral pulmonary embolism (pe), deep vein thrombosis (dvt), large thrombus burden in the pulmonary arteries, a history of recent myocardial infarction and was to undergo secondary cardiac intervention.Placement of the inferior vena cava filter was advised as medical service felt that vena cava interruption was necessary for the patient's medical safety during the secondary procedures.The patient was prepped and draped in normal sterile fashion, and the common femoral vein was punctured.Iliac venography was unremarkable with digital subtraction technique and nonionic contrast.The inferior vena cavogram; however, demonstrated an abnormally large inferior vena cava especially just below the renal arteries where the caval was greater in size.Therefore, the filter was placed in the lower lumbar aorta.A retrievable type of filter was utilized as this gave the greatest diameter relative to the ¿greenfield¿ filter and this could be retrieved later.Post placement, there was no evidence of evolving hematoma.The patient¿s vital signs remained stable and remained asymptomatic except for a chronic back discomfort which had been present for days.The operative report noted a low placement of the optease filter interruption device to prevent pulmonary embolus.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the inferior vena cava (ivc), tilting of the filter and embedment, becoming aware of these events approximately thirteen years after the filter implantation.The patient also reports edema from the waist down causing pain in the lower extremities, and further experienced anxiety related to the filter.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 12169840
• MDR Text Key: 261685184
• Report Number: 1016427-2021-05080
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220B
• Device Lot Number: R0607305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR