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

Model Number	1103
Medical Device Problem Codes	Battery Problem (2885); Pumping Problem (3016)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ventricular assist device (vad) exhibited low-flow events, and the patient experienced hypertension.Additionally, the controller exhibited a controller fault alarm due to internal battery end-of-life.The controller was exchanged, and the vad remains in use.
Additional Manufacturer Narrative
### investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system controller d4: model #: 1420- controller / catalog #: 1420 / expiration date: 31-aug-2023 / serial #: (b)(6) d9: no h3: no h4: mfg date: 01-aug-2022 h5: no ### 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: 50082463
• Report Number: 3007042319-2026-01111
• Device Sequence Number: 13347854
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: (01)00888707000017(17)160731
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup
• Report Date (Section B): 09/08/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male