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

Model Number 466FXXXX

Device Problem Unintended Movement (3026)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/17/2018

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 filter tilting with the apex of the filter in contact with the inferior vena cava (ivc) wall and possible embedment of the ivc filter.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 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.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.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of filter tilt could not be confirmed or further clarified.Additionally, the timing and mechanism of the events is unknown.Ivc filter tilt has been associated with operator technique, vessel characteristics, specifically asymmetry and tortuosity.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 physical and emotional damages from filter tilting with the apex of the filter in contact with the inferior vena cava (ivc) wall and possible embedment of the ivc filter.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b6, 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 filter tilting with the apex of the filter in contact with the inferior vena cava (ivc) wall and possible embedment of the ivc filter.The patient reported becoming aware of filter tilt and possible embedment approximately seven years and one-month post implant.The patient also reports abdominal pain related to the filter.According to the implant record the indication for the filter placement was pulmonary emboli.The filter was placed via the right common femoral vein and deployed with the tip of the filter at the level of the lowest renal vein inflow.The patient tolerated the procedure well and there were no immediate complications.Approximately seven years and one-month post implant, a computed tomography (ct) scan was performed due to abdominal pain.Results of the scan noted that the filter appeared to be tilted anteriorly within the ivc with the apex of the filter possibly in contact with the anterior wall.The filter does not appear to perforate the ivc wall and no fat plane was identified to support a diagnosis of perforation; however, the apex of the filter was in close approximation with a loop of small bowel.No fracture struts were identified.There is currently no additional information available for review.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.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/or vessel characteristics, specifically asymmetry and tortuosity.Pain does not represent a device malfunction and may be related to underlying patient specific issues.Without imaging available for review the reported events could not be confirmed or clarified nor a cause attributed.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

Additional information received per the medical records state that the indication for filter placement as pulmonary emboli.The filter was deployed via the patient's right common femoral vein.Using fluoroscopy, the filter was placed into the infrarenal area of the inferior vena cava.The tip of the filter was placed at the level of the lowest renal vein inflow.The patient tolerated the procedure well.There were no immediate complications.Approximately seven years and one month after the index, the patient underwent a computed tomography (ct) scan due to abdominal pain.The filter appeared to be tilted anteriorly within the inferior vena cava (ivc) with the apex of the filter possibly in contact with the anterior wall.The filter does not appear to perforate the ivc wall and no fat plane was identified to support a diagnosis of perforation; however, the apex of the filter was in close approximation with a loop of small bowel.No fracture struts were identified.  additional information received per the patient profile form (ppf) states that the patient experienced filter tilt, apex of the filter in contact with the inferior vena cava (ivc) wall and possible embedment of the ivc filter.The patient became aware of the reported events approximately seven years and one month after the index procedure.The patient continues to experience "abdominal and abdomen pain.".

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 10309023
• MDR Text Key: 200070110
• Report Number: 1016427-2020-04225
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: 15400773
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 21 GAUGE MICROPUNCTURE NEEDLE; UNKNOWN 5 FRENCH SHEAT; UNKNOWN CATHETER; UNKNOWN FRENCH INTRODUCER
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR