The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device alert concerning all retrievable inferior vena cava (IVC) filters.
The option to retrieve certain IVC filter models when no longer needed has only become available within the last 10 years. The MHRA has received relatively few adverse incident reports, but is aware of a high prevalence of retrieval related complications, through published papers and anecdotal reports.
For example, complications have arisen during attempted retrieval of filters with massive trapped thrombus, or which have undergone significant tilting, caval wall penetration, or loss of structural integrity while in situ.
In view of the serious complications associated with attempted IVC filter retrieval, the MHRA advises all physicians to:
- be aware of the various maximum implant durations for safe retrieval for each IVC filter model. The relevant clinical evidence and advice can be found in the manufacturer's instructions for use;
- retrieve the device as soon as possible once it is no longer clinically required;
- consider, and ideally schedule, the retrieval date at the time of implantation;
- have the patient undergoes a venogram, immediately prior to filter removal, to have an up-to-date assessment of the risks and benefits associated with the procedure;
- be aware that some retrievable filters become unsafe to remove due to progressive changes in their position, condition, orientation or thrombus within the filter;
- ensure that adequate systems are put in place to minimise the risk of patients being lost to follow-up;
- ensure patients are fully aware of the importance of attending future assessments, to reduce the number lost to follow-up;
- report all adverse events associated with the use of these devices.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON270690
Posted on 3 May 2013