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

Catalog Number 466F220A

Device Problem Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Date 10/23/2020

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 organ perforation and filter tilt.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.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 event.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 in 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 organ perforation and filter tilt.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, a patient had placement of an optease inferior vena cava (ivc) filter.Per the implant records, the indication was prophylactic for gastric surgery related to morbid obesity with propensity for deep venous thrombosis (dvt) and pulmonary embolus (pe).A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.The filter malfunctioned including organ perforation and filter tilt.Per the patient profile form (ppf), the patient reports ivc and organ perforation, filter tilt, blood clots at surgical site post implant, rectal bleeding, low hemoglobin, right leg swelling, breathing issues and anxiety related to the filter.A removal procedure was performed approximately fifteen years and two months after implant, complicated by low oxygen levels and admission to the icu.No further procedure details have been provided.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 and surrounding organs; 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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Rectal bleeding is not specifically listed in the device ifu; however, may be related to an accompanying anticoagulation regimen typically prescribed for ivc filter patients.The difficulty breathing and hypoxia may be related to the removal procedure and accompanying anesthesia administered for that procedure; however, can be related to other known adverse events associated to ivc filters.Anxiety and leg swelling do 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 in 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 organ perforation and filter tilt.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 preoperative diagnosis of morbid obesity with propensity for deep venous thrombosis (dvt) and pulmonary embolus (pe).The patient was prepped and draped in the usual sterile manner.A doppler was used to identify the right common femoral vein, and the right common femoral vein was then cannulated with needle.Under fluoroscopy a guidewire was passed to the level of the superior vena cava and an inferior venacavagram was then accomplished demonstrating the 2nd and 3rd lumbar vertebra and the bifurcation of the inferior vena cava (ivc) and the renal veins.A satisfactory inferior vena caval diameter was identified and deployment of the ivc filter at the 2nd and 3rd lumbar vertebra position was accomplished without migration.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 ivc, perforation of struts into organs and tilting of the filter becoming aware of these events approximately fourteen years and ten months after the filter implantation; and underwent a percutaneous removal of the filter about fifteen years and two months after the filter implantation.Procedural removal details were not provided.The patient further asserts to have suffered from blood clots at surgical site post implant, resulting in multiple hospitalizations and surgical intervention, in addition to rectal bleeding, low hemoglobin, right leg swelling and breathing issues.The patient further reports experiencing a difficult removal of the filter, having to be admitted to the coronary intensive care unit after the surgery for low oxygen levels and experiencing 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: 11684585
• MDR Text Key: 245985854
• Report Number: 1016427-2021-04902
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2008
• Device Catalogue Number: 466F220A
• Device Lot Number: R0805329
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 16-GAUGE NEEDLE; UNK CATHETER INTRODUCER; UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 41 YR