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

Model Number	1103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhagic Stroke (4417)
Date of Event	09/18/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient presented to the hospital unresponsive and was intubated.A ct scan of the brain/head demonstrated a large hemorrhagic stroke.The event was reported as neurological dysfunction/stroke.The patient was receiving coumadin (warfarin) and aspirin (asa) and was reported to be compliant with anticoagulation therapy.Anticoagulation was reported to be therapeutic at the time of the event.Due to the severity of the hemorrhagic stroke, the patient remained unresponsive and required mechanical ventilation.The patient's family discussed withdrawal of life-sustaining treatment, including discontinuation of hvad support.It is unknown whether the reported hemorrhagic stroke was related to the hvad system.No causal relationship between the device and the reported event has been established.It was subsequently reported that the patient was transitioned to hospice care.The hvad pump was turned off/disconnected, and life-sustaining treatment was withdrawn.The patient subsequently expired.The vad will not be returned.
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: 50934544
• Report Number: 3007042319-2026-01469
• Device Sequence Number: 9563742
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/29/2026

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 Expiration Date: 11/30/2019
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2017
• 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: Death
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 251 LB