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 Codes	Pain (1994); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a ventricular assist device (vad) presented with right shoulder pain, and an elevated lactic dehydrogenase (ldh) level of 1200.There was possible concern for thrombus formation.The ldh laboratory testing was conducted, confirming the elevated result.The vad remains in use.
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.
Additional Manufacturer Narrative
A supplemental report is being submitted for additional event details.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 hospitalized and had a computerized tomography (ct) and echocardiogram with no visible thrombus.The patient on an intravenous (iv) anticoagulant and their ldh has plateaued at 670.
Additional Manufacturer Narrative
A supplemental report is being submitted for analysis and investigation completion.Product event summary: (b)(6) was not returned for evaluation.This complaint is associated with a clinical adverse event.A review of the device history record was not performed as the reported event is not related to a manufacturing or servicing issue.Log file analysis revealed increased power consumption and estimated flows with intermittent increases of power consumption above the normal operating range throughout the analyzed period.Of note, the alarm file was not available for review.It was reported that thrombus was suspected and the patient received intravenous (iv) anticoagulant which reduced lactic dehydrogenase (ldh) levels.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible root causes of the observed high power event may be attributed to multiple factors, including but not limited to external factors such as thrombus formation/ingestion, inappropriate pump rotational speed, and/or patient related factors.Per the instructions for use, thrombus is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of thrombus events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, 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 - 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 55112-4391 ; 7635269277
• MDR Report Key: 24250889
• Report Number: 3007042319-2026-00100
• Device Sequence Number: 12843812
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: (01)00888707000017(17)190228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup
• Report Date (Section B): 02/17/2026

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: 02/28/2019
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 02/04/2026; 02/13/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/11/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICD: DVAB1D4, LEAD: 6935M62.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female