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

Model Number 1420

Device Problems Contamination (1120); Crack (1135); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the controller (b)(4) 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.Visual inspection of the returned controller revealed contamination within both power ports.Additionally, visual inspection under a 10x magnification revealed a hairline crack around power port two.An internal inspection did not reveal evidence of fluid ingress.Functional testing revealed that the no power alarm sounded briefly when both power sources were disconnected and a controller fault alarm was triggered during testing, indicating an internal battery issue.Internal inspection revealed that the internal nickel-metal hydride (nimh) battery, which powers the no power alarm, was swollen.After the internal battery was replaced, the controller pe rformed as intended.Analysis of the event log file revealed three (3) controller power up events with associated pump start events logged on (b)(6) 2022 at 09:11:09, 09:11:39 and 09:13:44.The controller was without power for 27 seconds, 22 seconds, and 1 minute 24 seconds, respectively.No anomalies were recorded leading up to the losses of power.Analysis of the alarm log file revealed two controller fault alarms logged on 22/jul/2021 at 09:07:42 and 09:48:14, indicating an issue with the internal battery.In addition, log files revealed that the controller was in use for more than two (2) years.Based on an investigation conducted under capa pr00381374, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Even though this capa is closed, con316215 falls within the bounds of this capa.The most likely root cause of the observed contamination within the controller ports event can be attributed to handling of the device.The most likely root cause of the controller fault alarms and brief no power alarm sound during bench testing events can be attributed to a reduced charge capacity of the internal nimh battery.Capa pr00492825 was opened to investigate internal battery issues with controller 2.0.A possible root cause of the losses of power to the controller can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr00551638 is investigating controller losses of power.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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller was returned to the manufacturer.The device subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16686586
• MDR Text Key: 312822129
• Report Number: 3007042319-2023-01330
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0067-2019
• Patient Sequence Number: 1