Thoratec Corporation initiated a worldwide medical device correction notification of all serial numbers of the HeartMate II® Left Ventricular Assist Systems (HM II LVAS) having Catalog No. 104692, 103393, 104911, or 104912. Thoratec took this action based upon reports of the sealed outflow graft bend relief not being properly connected to the HeartMate II LVAS. There have been 29 reported incidences of the defect. Of these 29 incidents, 24 were observed in x-ray images or during surgical procedures, and were thus unlikely to be related to patient symptoms. However, in at least one reported case, it is noted that the disconnected bend relief may have contributed to the need for reoperation. The bend relief is designed to prevent kinking of the outflow conduit that connects the HeartMate II pump to the ascending aorta.
Disconnection of the bend relief from the outflow graft may result in one or more of the following symptoms: low pump flow, hemolysis, fluctuations in pump flow, speed and/or power, or worsening symptoms of heart failure. It is also possible for bleeding to occur if the disconnected bend relief causes abrasion of the graft, and required repair in three patients.
For all new HeartMate II LVAS implant procedures, clinicians have been instructed to follow the revised instructions for use that clarify the recommended procedure for securing the bend relief to the outflow graft. Clinicians have also been advised to consider the possibility of a disconnected outflow graft bend relief if a HeartMate II LVAS patient exhibits symptoms such as low pump flow, hemolysis, bleeding, fluctuations in pump flow, speed and/or power, or worsening symptoms of heart failure.
The affected systems were distributed to 226 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalog number located on the label of the package. Devices that have been implanted can be identified by the catalog numbers on the adhesive labels that were provided for inclusion in the patient’s medical records.
See the FDA Announcement