Field Safety Notice Medtronic Evolut™ PRO+/FX/FX+ Bioprosthesis (ICN 2924)

NHSSC: 6

Alert:

• Medtronic has issued a Field Safety Notice regarding updates to the Instructions for Use (IFU) and Physician/Healthcare Practitioner Training related to potential damage to the bioprosthesis container (jar) upon opening.
• Medtronic has received reports of users having difficulty opening the jar, which may cause damage to the lid, resulting in the potential for particulate (see Figure 1 of the notice) transferring from the lid to the jar containing the bioprosthesis.
• Medtronic has no evidence of seal degradation and no evidence that the sterility of the bioprosthesis is compromised.
• If particulate material is observed in the solution upon opening the jar, the bioprosthesis should be discarded and a new unopened device used instead.
• In accordance with current Instructions for Use (IFU) and training, the bioprosthesis should always be rinsed with three rinsing bowls before use.

Products Affected:

• There are 11 NHS Supply Chain products affected.
• Please see the attached product listing and Field Safety Notice for more information on the affected products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Medtronic has initiated an action to update the applicable IFU for Evolut PRO+/FX/FX+ as follows:
  • “Do not use the bioprosthesis if there is any damage to the container (for example, cracked jar or lid, leakage, particulate material, broken or missing seals or jar lid gasket).”
• Please complete and return the Acknowledgment Form to: regulatoryuk-ire@medtronic.com
• If you encounter a damaged bioprosthesis please raise a product complaint – https://www.supplychain.nhs.uk/customer-service/submit-product-complaint/?utm_source=submit-a-product-complaint

If you have any concerns or further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.