• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CASHEL 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466F230AF
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2016
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient underwent placement of a optease vena cava filter. The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded to the wall of the inferior vena cava (ivc) and failed retrieval attempt. The patient also is reported to have developed clots in the stomach and legs, resulting in pain, after an initial attempt to retrieve the filter. The information also indicated that stenosis was identified within the ivc. The indication for the filter implant was a history of factor 5 hypercoagulation, leiden mutation, right lower extremity swelling and deep vein thrombosis (dvt). The filter was implanted via the right femoral vein and the filter was successfully deployed. Approximately three months post implant an unsuccessful percutaneous retrieval attempt was made. According to the information provided, the patient subsequently developed clots in the stomach and legs, resulting in severe pain. Approximately ten months post implant, the patient underwent a successful laser assisted retrieval of the filter. Imaging at that time demonstrated moderate ivc stenosis at the level of the renal veins. 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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation. Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. 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, thrombosis in the filter, vessel stenosis, and occlusion of the ivc do not represent a device malfunction, rather clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics. Without implant or retrieval images available for review the reported events could not be confirmed or further clarified. With the limited information available for review it is not possible to draw a clinical conclusion between the device and the reported events. 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.
 
Manufacturer Narrative
Additional information was received from a patient profile form that on the first attempt 3 months after filter placement at a percutaneous removal procedure was unsuccessful. Subsequently, the patient developed clots in his stomach and legs, resulting in severe pain. A cavagram about 7 months later demonstrated moderate ivc stenosis at the level of the renal veins. He underwent a successful laser assisted retrieval of the embedded filter and angioplasty of the ivc stenosis. At filter placement, the patient presented with factor 5 hypercoagulation, leiden mutation, right lower extremity swelling and deep vein thrombosis (dvt). The patient had successful infrarenal ivc filter deployment. (b)(4). Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
As reported, the patient underwent placement of defendants' optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded to the wall of the inferior vena cava (ivc) and failed retrieval attempt. 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 continue to suffer significant medical expenses, and pain and suffering, and other damages. The product was not returned for analysis. Additionally, as the sterile lot number was not available, device history record review could not be performed. The optease 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. Thrombosis within the inferior vena cava does not represent a device malfunction. The implantation date of the filter and the attempted retrieval date is unknown at this time. Retrieval of the optease vena cava filter is indicated up to 23 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, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days. Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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, the patient underwent placement of defendants' optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter embedded to the wall of the inferior vena cava (ivc) and failed retrieval attempt. 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 continue to suffer significant medical expenses, and pain and suffering, and other damages.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name466FXXXX
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
MDR Report Key7125242
MDR Text Key276581932
Report Number1016427-2017-00880
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number466F230AF
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/18/2017 Patient Sequence Number: 1
-
-