MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Unintended Movement (3026); Migration (4003)

Patient Problem Perforation of Vessels (2135)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

As reported, a patient underwent placement of an optease inferior vena cava (ivc) filter.Per the implant records, the indication was need for abdominal surgery with history of deep vein thrombosis (dvt) and pulmonary embolism (pe).Venography was performed demonstrating patency of the external and common iliac veins on the right side, the inferior vena cava as well as patency of the left renal vein and the lower most renal vein.The inferior vena cava (ivc) was adequate size to accommodate a filter and there was no venous anomaly.The optease retrievable filter was delivered slightly below the left renal vein without any problems or any tilt.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to malfunction, including perforation, tilting, migration and embedment that causes injury and damage to the patient.Per the patient profile form (ppf), the patient reports ivc perforation, filter migration, tilting and embedment, in addition to an unsuccessful percutaneous filter retrieval procedure attempted approximately two months after the filter was implanted.The patient further reports anxiety.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.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 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 malfunction, including perforation, tilting, migration and embedment that causes injury and damage to the patient.Per the implant records, placement of the filter was indicated as the patient was to undergo abdominal surgery and was reported to have a history of deep vein thrombosis (dvt) and pulmonary embolism (pe).Using ultrasound guidance to determine the patency of the vein and to guide the needle entry site, percutaneous catheterization of the right common femoral vein was completed, and a sheath was introduced.Venography was performed demonstrating patency of the external and common iliac veins on the right side, the inferior vena cava as well as patency of the left renal vein and the lower most renal vein.The inferior vena cava (ivc) was adequate size to accommodate a filter and there was no venous anomaly.The optease retrievable filter was delivered slightly below the left renal vein without any problems or any tilt.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately eight years after the filter implantation.The patient reports ivc perforation, filter migration, tilting and embedment, in addition to an unsuccessful percutaneous filter retrieval procedure attempted approximately two months after the filter was implanted.The patient further experienced anxiety related to the filter.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10217219
• MDR Text Key: 197337094
• Report Number: 1016427-2020-04123
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR