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

Catalog Number 466F200A

Device Problem Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Date 02/25/2021

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 organ perforation.The patient reported becoming aware of perforation of filter struts outside the ivc and perforation of struts into organs, approximately sixteen years and two months post implant.The patient also reported blood clots and extensive leg damage post implant, having to be on blood thinners, and anxiety related to the filter.Per the implant records, the patient presented with swelling in the right calf and a history of pulmonary emboli (pe).Duplex venous imaging confirmed deep venous thrombosis (dvt) of the right and left lower extremity, involving the distal superficial femoral vein, the popliteal and deep calf veins.Following left femoral access, the optease dilator and sheath were advanced over a guidewire.The optease filter was advanced and placed at the upper l2 level with its tip infrarenal.A cavagram, completed post procedure, showed good infrarenal placement of the filter.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.Blood clots 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 vessel characteristics.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.Without images available for review the reported events could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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 organ perforation.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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient presented with swelling in the right calf and a history of pulmonary emboli (pe).Duplex venous imaging confirmed deep venous thrombosis (dvt) of the right and left lower extremity, involving the distal superficial femoral vein, the popliteal and deep calf veins.Following left femoral access and performance of an inferior vena cava (ivc) cavagram, the optease dilator and sheath were advanced over a guidewire.The optease filter was advanced and paced at the upper l2 level with its tip infrarenal.A cavagram completed post procedure, showed good infrarenal placement of the filter.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc and perforation of struts into organs, becoming aware of these events approximately sixteen years and two months after the filter implantation.The patient further asserts to have suffered from blood clots and extensive leg damage post implant, having to be on blood thinners, and experienced anxiety related to the filter.

• Brand Name: OPTEASE PERMANENT FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12266089
• MDR Text Key: 264702887
• Report Number: 1016427-2021-05229
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466F200A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• 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
• Treatment: UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR