• 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
Model Number 466FXXXX
Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)
Patient Problems Occlusion (1984); Thrombosis (2100); Stenosis (2263)
Event Date 04/27/2011
Event Type  Injury  
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly. The following additional information received per the patient profile from (ppf) indicates that the patient underwent an unsuccessful attempt to remove the filter percutaneously a month and nineteen days post implantation. The patient also had blood clots, clotting, and occlusion of the ivc, pain, occlusive thrombus in the common iliac vein and ivc, partially in the common femoral and external iliac vein, dizziness and fatigue. According to the medical records, the patient was set to undergo a bilateral knee surgery replacement was at significant risk for developing deep vein thrombosis (dvt) and pulmonary emboli (pe) therefore the patient was referred for filter placement. The ivc measured 2. 5cm and the filter was deployed 1cm below the renal vein without any reported complications. As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter. Per the medical records, the patient was set to undergo a bilateral knee surgery replacement was at significant risk for developing deep vein thrombosis (dvt) and pulmonary emboli (pe) therefore the patient was referred for filter placement. The ivc measured 2. 5cm and the filter was deployed 1cm below the renal vein without any reported complications. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, occlusion of inferior vena cava (ivc) at filter level, causing complete occlusion and stenosis of the iliac and femoral veins, with collaterals, requiring prolonged lytic therapy, thrombolysis, angioplasty procedures, and stent placement; failed retrieval attempt; incorporation of filter into caval wall; and unable to retrieve filter, despite only being intended for temporary use. 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 following additional information received per the patient profile from (ppf) indicates that the patient underwent an unsuccessful attempt to remove the filter percutaneously a month and nineteen days post implantation. The patient also had blood clots, clotting, and occlusion of the ivc, pain, occlusive thrombus in the common iliac vein and ivc, partially in the common femoral and external iliac vein, dizziness and fatigue. The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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 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. Blood clots and occlusive thrombosis within the filter and lower extremities do not represent device malfunctions. Venous stenosis is a known potential adverse event associated with implantation of devices within the vasculature, and is listed in the ifu. Dizziness and fatigue do not represent device malfunctions and may be related to underlying patient related issues. Clinical factors that may have influenced the event include patient comorbidities, pharmacological and lesion characteristics. 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.
 
Manufacturer Narrative
Complaint conclusion: as reported by the legal department, the plaintiff underwent placement of an optease vena cava filter on or about (b)(6) 2012. The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, occlusion of ivc at filter level, causing complete occlusion and stenosis of the iliac and femoral veins, with collaterals, requiring prolonged lytic therapy, thrombolysis, angioplasty procedures, and stent placement. Failed retrieval attempt; incorporation of filter into cava wall and unable to retrieve filter, despite only being intended for temporary use. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, 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 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. Thrombosis does not represent a device malfunction. Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined. The reported event notes implantation of the filter on or about (b)(6) 2012; however, 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 has been shown to lead to explantation problems after 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 department, the plaintiff underwent placement of an optease vena cava filter on or about (b)(6) 2012. The filter subsequently malfunctioned and caused injury and damages to the patient. Including, but not limited to, occlusion of ivc at filter level, causing complete occlusion and stenosis of the iliac and femoral veins, with collaterals, requiring prolonged lytic therapy, thrombolysis, angioplasty procedures, and stent placement. Failed retrieval attempt; incorporation of filter into cava wall and unable to retrieve filter, despite only being intended for temporary use. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, 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
miami FL
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
miami FL
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6338799
MDR Text Key269513317
Report Number1016427-2017-00179
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number466FXXXX
Device Catalogue Number466FXXXX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/24/2017
Event Location No Information
Date Manufacturer Received12/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/17/2017 Patient Sequence Number: 1
-
-