Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Micra Delivery System [packaged as part of Micra Transcatheter Pacing System Model: MC1VR01].
The manufacturer is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the affected product during implant. The following information is included "Once the tether is cut, do not flush the delivery system until the tether has been fully removed".
According to the manufacturer, as of 18 Jul 2019, there have been 52 complaints worldwide involving a tangled tether during tether removal that resulted in prolonged or additional procedures. No deaths have been reported related to this issue. The manufacturer has identified flushing the delivery system after the tether has been cut may cause the free end of the tether to enter the ventricular chamber and tangle. The tangle could potentially prevent tether removal from the delivery system and potentially prevent release of the Micra pacemaker. It could resulted in prolonged or additional procedures. The manufacturer recommended that some amount of resistance during tether removal is normal. Tension or resistance during tether removal is not typically indicative of a tangle. If user feel resistance when pulling out the tether, advance the recapture cone closer and/ or more coaxially to the device.
The functionality of the Micra pacemaker is not affected by this update. No action is needed for patients already implanted with a Micra device, as this update to instructions applies only to new implant procedures.
Users are advised to implement this new instruction in all future Micra implants. Upon regulatory approval, the updated IFU will be available online. The updated Tip Card includes a revision date of Aug 2019 or later, can be accessed at the manufacture's website, or by contacting the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 7 August 2019