The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom posted a medical device safety alert concerning Pipeline Embolization Device (Pipeline Classic), Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire, UltraFlow HPC Flow Directed Microcatheter and Marathon Flow Directed Microcatheter manufactured by Medtronic. All lot numbers that have a use by date between June 2017 and August 2019 are affected. For the Pipeline Embolization Device, the issue only affects the delivery wire. The implant itself is not affected
The manufacturer has identified the potential for an issue with a specific set of lot numbers of Medtronic Neurovascular products where the PTFE (polytetrafluoroethylene) coating could delaminate and separate from the delivery wire.
Through 27 September 2016, the manufacturer has received a total of five reports for the products that are potentially affected by this issue. The manufacturer has received no reports of serious injuries or patient death as a result of this issue.
According to the manufacturer, delamination and detachment of the PTFE coating material may lead to PTFE coating in the blood stream. PTFE in the blood stream, depending on its specific size and quantity, could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial edema, peripheral edema, incomplete treatment, infection, local inflammatory response, systemic inflammatory response, ischemic stroke, lysis/necrosis, neurological deficit, organ impairment, shock, space occupying lesion, thrombosis, and hemorrhage.
The manufacturer is recalling the affected products. Customers are advised to quarantine and remove all unused affected products in their inventory. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with standard patient management protocol.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-3-7-october-2016
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 October 2016