MAUDE Adverse Event Report: HeartWare, Inc. HeartWare Ventricular Assist System - Pump; VENTRICULAR (ASSISST) BYPASS

Model Number	1103
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Codes	Fatigue (1849); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a ventricular assist device (vad) patient experienced frequent low-flow alarms, fatigue, and an upper gastroint estinal bleed (gib).The patient underwent upper esophagogastroduodenoscopy (egd) to identify the location of the bleed.During the procedure a polypectomy was performed.The patient received a packed red blood cells (prbc) infusion.  the vad remains in use.  no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.### medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HeartWare Ventricular Assist System - Pump
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HeartWare, Inc.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HeartWare, Inc.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50867493
• Report Number: 3007042319-2026-01450
• Device Sequence Number: 9425889
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: (01)00888707003261(17)201130
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2018
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female