Safety Alert Or Field Safety Notices for OPTEASE® retrievable vena cava filter

Safety alert / Field Safety Notice

MDA/2014/001

CON357135

2014-01-02

2014-01-02

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON357135?tabName=allTabs

Risk of serious patient injury from the migration of a wrongly orientated inferior vena cava (ivc) filter. on 8 october 2013 cordis corporation issued an urgent field safety notice recalling 217 distributed lots of the optease retrievable vena cava filter, due to a printing error in the device labelling. the error involved the access site arrow pointing the wrong way on the storage tube for a filter intended to be placed using the femoral approach, and resulted in the filter being implanted upside down. the filter had to be retrieved percutaneously to remove the risk of it migrating towards the patient’s heart, because the filter’s retaining barbs would have provided no migration resistance. the procedure had to be completed using a jugular approach, contrary to the instructions for use, because the retrieval hook was orientated upwards in the cranial direction. the affected optease filters were manufactured between november 2010 and august 2013. cordis has confirmed that all unused filters have now been recalled, and that no other instances of incorrect arrow orientation have been found from inspection of over 10,000 storage tubes manufactured at the same time as distributed product. the mhra is issuing this medical device alert because the manufacturer’s fsn does not have advice on the management of patients already implanted with an optease ivc filter. cranial migration of any ivc filter carries a fatal risk to the patient. although the risk of migration may decrease the longer the implant has been in place as the filter becomes embedded in the caval wall, there are no data to confirm a time at which migration would no longer occur. cordis corporation currently manufactures two distinct models of ivc filter: the trapease ® permanent vena cava filter, not designed to be retreived. it has no retrieval hook and has bi-directional retaining barbs. therefore orientation is not critical. the optease® retrievable vena cava filter, a temporary filter designed to be retrieved within 12 days (after which it is considered a permanent implant). it has retaining barbs that are uni-directional, and must therefore be implanted in one orientation only (see fsn dated 3 april 2013). it incorporates a retrieval hook which should always point in the caudal direction (irrespective of implantation route) to facilitate femoral retrieval, and to ensure that the retaining hooks are securing the filter against migration.

For all patients implanted with an affected OPTEASE IVC filter: Review retained post-op images to check whether the implanted filter is correctly orientated, which is with the retrieval hook in the caudal direction. Recall for rescreening all patients for whom correct orientation cannot be confirmed. These patients should be recalled as soon as possible, prioritising those with the most recent implants. Weigh the serious risk of filter migration against the risk of a re-intervention for a filter that is implanted upside down. Both risks may vary according to how long the implant has been in place, and should be assessed for each patient individually. Be aware that re-intervention, where considered appropriate, should be undertaken as soon as possible, and would require a jugular approach. Ensure that all IVC filters are correctly orientated prior to loading into the delivery system and insertion into the patient. Note that the filter’s retaining barbs protect against migration in only one direction.