Medical device manufacturer, Getinge, has issued a medical device safety alert concerning its HEMASHIELD GOLD--Knitted Microvel Double Velour Vascular Graft and HEMASHIELD PLATINUM--Woven Double Velour Vascular Graft.
According to the manufacturer, the issue was identified through five complaints received between July 2018 and September 2019 reporting intra-operative bleeding at the seam line of the branches of Hemashield grafts.
The investigation was focused on the method used to assemble the branches because the leak was reported at the seamline. This process is performed by operators using different sewing techniques. It was noticed that the products involved in the mentioned events were prepared by the same operator.
The most likely occurrence, as a consequence of the issue, is a procedural delay due to the necessity to adopt additional hemostatic measures. The delay is expected to be limited and not impacting the flow of the operation and its outcome. Intraoperative bleeding has been observed when the blood flow has been established through the vascular graft and it was controlled either by compression, clotting agent application or a simple suture. This however, can rarely result in serious or even critical situations especially for patients at greater risk. Reoperation to control postoperative bleeding is a remote possibility that has not been observed. The presence of mediastinal drainage will help in promptly detect an unusual bleeding. The criticality of this event for the high-risk population derives from the need of a re-operation and the potential impact on the already delicate overall condition.
Based on the medical evaluation by the manufacturer, only those which are not implanted need to be recalled. Explantation of products is not recommended.
Affected users should ensure that all non-implanted products are segregated in a secure storage place to prevent any use of these products. Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 March 2020