The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, manufactured by Micro Therapeutics Inc DBA ev3 Neurovascular (sponsored by Medtronic). The affected devices are identified as the following:
According to the TGA, the manufacturer has identified the potential for device fracture at the distal section during use due to a weakened bond in a subset of devices that have been recently manufactured. Use of affected product may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If this occurs, it may result in significant patient injury, including a prolonged procedure, ischemic stroke, intracranial haemorrhage, neurological deficit, and/or death. No complaints related to the issue have been confirmed within the affected population at this time.
This is a peri-procedural risk. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to the patients due to the issue. Those patients with an implanted device should continue with their normal course of treatment.
The manufacturer is advising customers to remove and quarantine all unused affected products. Users should not use any affected product. Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
For details, please refer to the following link:
https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2020-RN-00183-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 February 2020