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

Model Number 1420

Device Problems Use of Device Problem (1670); Battery Problem (2885); Power Problem (3010)

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

Event Date 12/19/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was confused and accidentally performed a double disconnect of power on the controller and triggered a loss of power and no power alarm.The patient reconnected the power and shortly the controller exhibited a controller fault alarm that did not clear.As per log files, the controller exhibited controller fault alarm due to internal battery end of life.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Visual inspection of the controller revealed contamination within both power ports.This is an additional observation not related to the reported event, likely due to the handling of the device.Additionally, visual inspection under 10x magnification revealed hairline cracks around power ports one (1) and two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.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, (b)(6) falls within the bounds of this capa.Functional testing revealed that the no power alarm sounded briefly when both power sources were disconnected from the controller and a controller fault alarm was triggered during bench testing, indicating an issue with the internal battery.Internal inspection revealed that the internal nickel-metal hydride (nimh) battery which powers the no power alarm was swollen.After the battery was replaced, the controller performed as intended.Analysis of the event log files revealed a controller power up with an associated motor start event logged on (b)(6) 2020, at 17:40:01.The data point prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 25% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 25% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port (1) and (b)(6) was connected to power port two (2).The controller was without power for sixteen (16) seconds.No anomalies were observed leading up to the loss of power.Review of the alarm log file revealed a controller fault alarm logged on (b)(6) 2020 at 18:18:28, indicating an issue with the internal battery.Additionally, log files revealed that the controller was in use for more than 2 years.As a result, the reported event was confirmed.Based on the available information, the most likely root cause of the loss of power can be attributed to the reported disconnection of both power sources from the controller as described in the event details.The most likely root cause of the controller fault event 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.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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 11101948
• MDR Text Key: 225128380
• Report Number: 3007042319-2020-08073
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000475
• UDI-Public: 00888707000475
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0067-2019
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Age: 31 YR