Medical device manufacturer, Thoratec Corporation, has issued a field safety notice on the use of Thoratec HeartMate II® Left Ventricular Assist System. The affected devices included all lot numbers of the HeartMate II® Left Ventricular Assist System
Sealed Outflow Graft Short Bend Relief (Catalog No. 104692) and Thoratec HeartMate II Sealed Outflow Graft (Catalog No. 103393). All serial numbers of the Thoratec HeartMate II Implant Kit with Sealed Grafts (Catalog Nos. 104911 and 104912).
The manufacturer is aware of a recent trend in reports of disconnection of the bend relief from the sealed outflow graft, a component of the HeartMate II LVAS. The bend relief is a tube of ePTFE surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft.
Disconnection of bend relief from the sealed outflow graft may potentially lead to outflow graft kinking and/or graft abrasion. Symptoms of outflow graft kinking included low pump flow, hemolysis, bleeding, and fluctuations in pump flow, speed and/or power, or worsening symptoms of heart failure. Graft abrasion may lead to serious bleeding.
So far, the manufacturer has identified 29 reports of disconnected bend relief. Five of the reports had symptoms of outflow graft kinking with one of them died of multi-organ failure. However, it is not clear as to what extent the disconnected outflow graft bend relief may have caused or contributed to this patient's condition. Besides, there were also three reports of serious bleeding that might be due to graft abrasion.
According to the local supplier, the affected device has been distributed in Hong Kong but there were no similar adverse events reported here. If you are in possession of the product, please contact your supplier for necessary actions.