• 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 OPTEASE RETRIEVAL FILTER 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 OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 466F220A
Device Problem Unintended Movement (3026)
Patient Problems Occlusion (1984); Thrombosis (2100)
Event Date 07/22/2016
Event Type  Injury  
Manufacturer Narrative

It was reported that a underwent placement of an optease vena cava filter. The indication for the implant was a pulmonary embolism. According to the information received the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, migration of the inferior vena cava (ivc) filter. 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 following additional information received per the patient profile from (ppf) indicates that on or about three years and three months post implantation the patient had blood clots, clotting and occlusion of the ivc. It is also noted in the patient profile form that the device was unable to be retrieved, however, there is no documentation indicating that an attempt to retrieve the filter took place. The documentation also indicates that the patient experiences pain at the site of the filter placement. The patient was noted to be high- risk for hypertension and dyslipidemia. The filter was deployed with no complications during the index procedure. The product was not returned for analysis 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. Blood clots and thrombosis within the filter do not represent a device malfunction. Without procedural films and post implant imaging available for review, the reported filter migration, clotting, blood clots and vena caval occlusion could not be confirmed and the exact cause could not be determined. The instructions for use (ifu) states that migration is a potential complication associated with vena cava filters. With the limited information provided it is not possible to establish a relationship between the reported events of fracture and migration of the device. Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined. Given the limited information available for review, a relation between the device and the event(s) could not be determined. Pain does not represent a device malfunction. 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. This report is a follow up report to mfr number 9616099-2016-00514 that was submitted under the previous complaint handling software system. The information has been duplicated from the first report with additional information added.

 
Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, migration of the inferior vena cava (ivc) filter. 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 following additional information received per the patient profile from (ppf) indicates that on or about three years and three months post implantation, the patient had blood clots, clotting and occlusion of the ivc. According to the medical records, the indications for the procedure was pulmonary embolism (pe). The patient was noted to be high risk for hypertension and dyslipidemia. The filter was deployed with no complications during the index procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTEASE RETRIEVAL FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7156085
MDR Text Key96109844
Report Number1016427-2017-00925
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number466F220A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/29/2017 Patient Sequence Number: 1
-
-