HeartWare

Ventricular Assist Systems

HeartMate 3 Important Field Safety Notice Jan 2018

Recall

Outflow Graft Clip issue

1 Page

IMPORTANT FIELD SAFETY NOTICE HeartMate 3™ Left Ventricular Assist System Catalog #106524INT LVAS KIT, HM3 Outflow Graft Clip Catalog #10012390GBL January 7, 2018 Dear Physician, In May 2018, we provided you information associated with HeartMate 3 (HM3) Outflow Graft twist occlusions and a forthcoming design improvement... bbott is now informing our physician partners that the Outflow Graft Clip has recently received CE mark approval... he Outflow Graft Clip has been designed to prevent any rotation of the outflow graft, thus eliminating the safety concern reported in the May 2018 notice... he Outflow Graft Clip is intended to be used with all new patient implants and may be used on patient cases where an Outflow Graft twist is confirmed and surgical intervention is required... ll HM3 implanting centers are required to be trained on the proper attachment of the clip prior to use of the clip... ew HM3 kits sent to you will include the Outflow Graft Clip, and clips will be provided at no charge for all HM3 inventory currently available at your implanting center... bbott recommends the following updated patient management strategies for patients implanted with HM3... pdated Patient Management – New Patients • During implant, when attaching the Outflow Graft to the Pump Cover, a clicking sound will be heard as the Screw Ring is tightened... ontinue turning the Screw Ring clockwise until it comes to a complete stop and stops clicking... o avoid damaging the Outflow Graft assembly, do not use tools to tighten the screw ring... Once the screw ring is tightened, apply the Outflow Graft Clip according to the provided Instructions For Use... pdated Patient Management – Ongoing Patients • For patients who are not experiencing any evidence of an outflow graft obstruction, Abbott recommends standard of care follow-up as previously outlined in the May 2018 notice without performing a surgical intervention to apply the Outflow Graft Clip... For patients previously implanted with the HM3 who are experiencing an outflow graft obstruction and require a surgical intervention to repair the obstruction, Abbott recommends applying the clip at the time of surgical intervention according to the Outflow Graft Instructions for Use... s a reminder, this is not a new issue but a continuation of the previous communications related to field reports of Outflow Graft twist... e kindly ask you to provide updated patient care based on the patient management recommendations outlined above... f you have questions, please contact your local Abbott MCS Clinical Specialist or the emergency MCS Hotline +32 22006645, which is available 24 hours a day, 7 days a week... hank you for your continued support... incerely,
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