• 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 Filter (816); Fracture (1260); Difficult to Remove (1528); Retraction Problem (1536)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 05/09/2013
Event Type  Injury  
Manufacturer Narrative

As reported, the patient underwent placement of the optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, two failed retrieval attempts, embedment of the filter into the ivc wall, caudal retraction of the filter resulting in deformation of the ivc, filter fracture, and complex removal of filter and two fractured struts. 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 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 fracture and retrieval difficulty could not be confirmed and the exact cause could not be determined. The implantation date and attempted retrieval date are 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. The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. 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 team, the patient underwent placement of the optease vena cava filter. The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, two failed retrieval attempts, embedment of the filter into the ivc wall, caudal retraction of the filter resulting in deformation of the ivc, filter fracture, and complex removal of filter and two fractured struts. 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, tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key7146818
MDR Text Key95791057
Report Number1016427-2017-00914
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 OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number466FXXXX
Device Catalogue Number466FXXXX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/27/2017
Event Location No Information
Date Manufacturer Received06/03/2018
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: 12/26/2017 Patient Sequence Number: 1
-
-