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

Model Number 466FXXXX

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 05/17/2019

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.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.Perforation of the ivc was reported, however a clinical conclusion could not be determined as to the cause of the event.Without post implant images for review, the reported filter perforation could not be confirmed or further clarified.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications associated with ivc filters.Given the limited information currently available for review, 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 that causes injury and damage to the patient.

Event Description

According to the medical records the patient had a history of motor vehicle accident, multiple lumbar fractures, severe deep vein thrombosis in the right lower extremity and morbid obesity.The filter was implanted via the patient's left femoral system.The filter was placed at the l2 interspace just below the left renal vein, it was well above the iliac bifurcation.A post procedural cavogram confirmed the location.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava.The patient became aware of the reported event approximately thirteen years and six months after the index procedure.Sixteen years and four months after the implant, there was an unsuccessful percutaneous removal attempt.The patient continues to experience worry, anxiety related to the filter.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.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.The patient reported becoming aware of perforation of filter strut(s) outside the inferior vena cava (ivc), approximately thirteen years and six months post implant.Sixteen years and four months post implant there was an unsuccessful percutaneous removal attempt, and the patient also reported anxiety related to the filter.According to the medical records the indication for the filter implant was status post motor vehicle accident and resultant multiple lumbar fractures and severe deep vein thrombosis in the right lower extremity.The patient was also noted to be morbidly obese.The filter was implanted via the left femoral system and deployed at the l2 interspace just below the left renal vein and well above the iliac bifurcation.A post procedural cavagram confirmed the location.The product remains implanted and unavailable 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 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.Usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.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.Perforation of the ivc was reported, however a clinical conclusion could not be determined as to the cause of the event.Without post implant images for review, the reported filter perforation could not be confirmed or further clarified.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications associated with ivc filters.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• 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: 10221039
• MDR Text Key: 197337331
• Report Number: 1016427-2020-04127
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2007
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: R1204522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2005
• 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: UNKNOWN 6-FRENCH SHEATH; UNKNOWN CATHETER WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Race: White