MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE; Ventricular (assist) bypass

Model Number	106523
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Specific patient information and device serial number are documented as unknown.Details are listed in the attached article.Device was implanted at time of event.Date of event has been entered as 01jan2023 since the patients were implanted between 2013 to 2023.Silvia ajello et al., asaio journal70.11: e150-e152.Doi: 10.1097/mat.0000000000002201.Cardiac intensive care unit, istituto di ricovero e cura a carattere scientifico (irccs) san raffaele scientific institute, milan, italy.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist systems (lvas) and the reported events could not conclusively be established through this evaluation.The serial numbers of the heartmate 3 left ventricular systems in use were not provided.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), revision b, is currently available.Section 1, "introduction," lists bleeding as an adverse event which may be associated with the use of heartmate 3 lvas.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported through the research article titled ¿impella as bridge to durable left ventricular assist device in acute myocardial infarction cardiogenic shock patients?¿ identifying that heartmate 3 (hm3) may be related to bleeding post-left ventricular assist device (lvad) implant that required surgical revision.From 2013 to 2023, 21 patients with cardiogenic shock after acute myocardial infarction were supported with an impella device as a bridge to durable lvad implantation.All patients (100%) were successfully bridged to durable lvad implantation.Seven patients (33%) were implanted with the heartware lvad (hvad; medtronic inc.), and 14 (67%) with the heartmate 3.After lvad implant, 5 patients (24%) required surgical revision for bleeding within 48 hours, and 8 patients (38%) required surgical revision for bleeding within 7 days post-lvad implant.This data first showed that bridging acute myocardial infarction complicated by cardiogenic shock (ami-cs) patients to durable lvad implantation with an impella device was feasible within few weeks from the index event in all patients.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE
• Common Device Name: Ventricular (assist) bypass
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21148381
• Report Number: 2916596-2025-00230
• Device Sequence Number: 21115902
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: (01)00813024013266
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 106523
• Device Catalogue Number: 106523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown