Update on pump weld non-conformance with the HeartWare™ Ventricular Assist Device (HVAD™) System

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited, as a follow-up to their earlier communication in May 2022, to update healthcare professionals on the number of adverse events, adverse events’ details, and root cause investigation of a pump weld non-conformance with the HeartWare^™ Ventricular Assist Device (HVAD^™) System. Patients with affected devices may present with signs and symptoms that resemble pump thrombus. The investigation determined that the occurrence of a weld crack resulted from a combination of factors that may include the initial presence of contamination in the weld area from previously applied substances as part of the manufacturing process, the misalignment of the cap and housing prior to welding, or the depth/thickness of the weld. Medtronic’s investigation was not able to conclusively isolate this issue to a specific subset of pumps. There are no new patient management recommendations since the earlier communication. Routine prophylactic explantation of the HVAD^™ device is not recommended, as risks associated with explantation may outweigh the potential benefits. Healthcare professionals are advised to make the decision regarding explantation and exchange of the HVAD^™ pump on a case-by-case basis, considering the patient’s clinical condition and surgical risks. For patients presenting with any of the signs and symptoms that resemble pump thrombus, healthcare professionals are advised to consider whether the clinical presentation could be due to a pump thrombus and treat accordingly. Please refer to the letter for details. Published: 28 Jul 2022

Dear Healthcare Professional Letters