MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT; VENTRICULAR (ASSISST) BYPASS

Model Number	1125
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the outflow graft exhibited kinking, specifically a 90 degrees kink located 3.5cm from the anastomosis site, as confirmed by computed tomography (ct) imaging.The ventricular assist device (vad) patient presented with edema, shortness of breath, and heart failure.The patient will receive a stent as treatment for the outflow graft kinking.The vad outflow graft remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted as additional information has being received for this event and sections have been updated.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.
Event or Problem Description
It was further reported that the patient was admitted and remains hospitalized.The patient received a stent for the outflow graft and was successful.There was no damage to the strain relief.The physician has not indicated any changes to the patient's routine therapy.
Additional Manufacturer Narrative
A supplemental report is being submitted for analysis and investigation completion.Product event summary: (b)(6) and the associated outflow graft (lot no.2002843580) were not returned for evaluation.A review of the device history record was not performed as the reported event and analysis are not related to a manufacturing or servicing issue.Information, including visual evidence, provided by the site indicated that there was kinking of the outflow graft.Additionally, log file analysis revealed intermittent decreases in power consumption and estimated flows between (b)(6) 2025 and (b)(6) 2025; however, no low flow alarms were logged.As a result, the reported outflow graft kinking event was confirmed.Based on the available information, the device may have caused or contributed to the low flow event.Based on the risk documentation and available information, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, kinked outflow graft, outflow graft obstruction, and poor vad filling.Per the instructions for use, worsening heart failure and respiratory dysfunction are known potential complications associated with implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of respiratory dysfunction events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related c omorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.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 - OUTFLOW GRAFT
• 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 55112-4391 ; 7635269277
• MDR Report Key: 23977603
• Report Number: 3007042319-2026-00015
• Device Sequence Number: 19978093
• Product Code: DSQ
• UDI-Device Identifier: 00888707007641
• UDI-Public: (01)00888707007641(17)220228
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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: 02/28/2022
• Device Model Number: 1125
• Device Catalogue Number: 1125
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 01/07/2026; 02/13/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/08/2026; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1104 VAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male