MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number	1420
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report is being submitted for analysis and investigation completion.Product event summary: the controller (b)(6) was returned for evaluation.No device malfunction was reported against the controller; therefore, the purpose of this investigation is solely to evaluate the device conformance to internal release requirements and/or to identify anomalies potentially introduced during use that may have prevented the device from performing as intended.A review of the manufacturing documentation was not performed as the analysis is not related to a manufacturing or servicing issue.Log file analysis did not reveal any anomalies; the returned controller was not in use.Failure analysis revealed that the controller passed visual inspection and functional testing.Internal visual inspection revealed cracks in one of the standoff posts of the controller housing.Based on an investigation, the root cause of the standoff post cracks was determined to be due to mineral oil applied to the controller¿s internal main gasket and/or to the silicone adhesive applied around the controller¿s internal battery coming into contact with the standoff post.The mineral oil and/or silicone adhesive contributed to environmental stress cracking.Capa pr00517125 is investigating this issue.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.
Event or Problem Description
The controller was returned to the manufacturer.Manufacturer's analysis subsequently revealed a mechanical problem was identified.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• 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: 22340975
• Report Number: 3007042319-2025-01379
• Device Sequence Number: 9172288
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: (01)00888707000420(17)190131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown