The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a device alert relating to certain lots of OPTEASE® retrievable vena cava filter, manufactured by J&J’s Cordis Corporation.
The newly issued MHRA alert follows Cordis’ own Field Safety Notice which it distributed back on 8 October 2013. That Notice remanded a recall of 217 distributed lots of the OPTEASE retrievable vena cava filter, due to a printing error in the device labelling.
While that might sound like the usual sort of paper exercise, the reality is that the labelling showed access site arrow pointing the wrong way on the storage tube for a filter intended to be placed using the femoral approach. The customer complaint that resulted detailed the filter being implanted upside down.
This meant 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 removal procedure would have to be completed using a jugular approach, contrary to the instructions for use, because the retrieval hook was orientated upwards in the cranial direction.
All affected lots of OPTEASE filters (Lot number 15960131 or below,manufactured between November 2010 and August 2013) have now been recalled, and no other instances of incorrect arrow orientation have been found from inspection of over 10,000 storage tubes manufactured at the same time. The MHRA says it 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 clearly 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.
The Alert points out that Cordis Corporation manufactures two distinct models of IVC filter, and that this notification only applies to the Optease iteration, Trapease being permanently implanted and as such not subject to the same issue.
So what to do for a patient implanted with an affected device?
The guidance says you should review retained post-op images to check whether the implanted filter is correctly orientated, which is with the retrieval hook in the caudal direction.
All patients for whom correct orientation cannot be confirmed should be recalled for rescreening as soon as possible, prioritising those with the most recent implants.
The serious risk of filter migration should be weighed 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.