Thoratec Corporation has initiated a voluntary worldwide medical device correction notification for its HeartMate II Left Ventricular Assist Systems (LVAS), following reports of the sealed outflow graft bend relief not being properly connected to the HeartMate II LVAS. 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. According to the recall notice, there have been 29 reports of this malfunction occurring. In at least one reported case, it was noted that the disconnected bend relief may have contributed to the need for reoperation.
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. Patients should be treated according to best clinical judgment and standard clinical practice guidelines. Clinicians have also been advised to immediately report to Thoratec any additional cases of disconnected outflow bend reliefs.
The affected systems were distributed to 226 hospitals and distributors throughout the United States, Europe, Canada and other countries. The devices subject to the notice include all serial numbers bearing catalog numbers 104692, 103393, 104911, or 104912. They 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.
Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).