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MHRA issues medical device alert relating to OPTEASE® retrievable vena cava filter manufactured by Cordis Corporation

Medical device safety body warn of risk of serious patient injury from the migration of a wrongly orientated inferior vena cava (IVC) filter.

3 January 2014

The Medicine and Healthcare Products Regulatory Agency (MHRA) has issued a medical device alert relating to the OPTEASE® retrievable vena cava filter, manufactured by Cordis Corporation (lots with number 15960131 or below).

An IVC filter is a medical device that is used by radiologists or vascular surgeons and implanted in the inferior vena cava to reduce the possibility of pulmonary emboli which can be life-threatening.

The manufacturers of the OPTEASE retrievable vena cava filter, Cordis Corporation, issued an urgent Field Safety Notice on 8.10.13, recalling more than 200 batches of the device because of a printing error in the device labelling.

The mistake 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 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 percutaneous approach via the jugular vein, contrary to the instructions for use, because the retrieval hook was orientated upwards in the cranial direction.

The affected devices were manufactured between November 2010 and August 2013.

The MHRA has issued a medical device alert about this device because the manufacturer’s Field Safety Notice does not offer advice on how patients should be managed when they have been implanted with an
OPTEASE IVC filter.

Cranial migration of any IVC filter poses a potentially fatal risk to the patient.

The MHRA recommends that clinicians who have responsibility for patients who have been fitted with an affected OPTEASE IVC filter should do the following:
 
  • 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.

To speak to a member of the medical device claims team please contact Jill Paterson on 020 7650 1219 for a free and confidential initial discussion.

Information was correct at time of publishing. See terms and conditions for further details.

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