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

Model Number 1420

Device Problems Bent (1059); Device Inoperable (1663); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that several batteries were not connecting to a power port of the controller, which had a bent pin on the power port.The controller was exchanged.During the controller exchange, there was a loss of power.The original controller was only connected to one power source and a loud continuous sound was heard right before the driveline was disconnected from that controller.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A 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 events.Failure analysis revealed that the returned controller passed functional testing.Visual inspection of controller under 10x magnification revealed a hairline crack around power port one and two.An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks were related to the reported event.Based on an internal investigation, the root cause of the hairline crack 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.Failure analysis of the returned controller also revealed a bent pin within power port one of the controller.The bent pin would not allow a battery to properly connect to a controller.As a result, the reported bent pin was confirmed.The most likely root cause of the reported bent pin in the controller power port can be attributed to a misalignment between the power port and battery output connector.An internal investigation was opened to investigate bent/damaged pins with controller 2.0.Log files analysis of controller revealed one reactivation event on (b)(6) 2018, at 12:50:55 due to an open phase on the front stator.A vad stop alarm was then logged on (b)(6) 2018, at 12:50:56 due to a disconnection of the driveline from the controller.As a result, the reported loud continuous alarm was confirmed.Log file analysis did not reveal any power up events on the reported event date.As a result, the reported loss of power could not be confirmed; it is possible the reported event details is referring to the vad disconnect alarm.The most likely root cause of the vad disconnect alarm can be attributed to a marginal connection between the driveline connector and controller.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Additional information was received regarding the recall number.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.

• 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
• MDR Report Key: 7648042
• MDR Text Key: 112748139
• Report Number: 3007042319-2018-02774
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• 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,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1336-2021
• Patient Sequence Number: 1
• Treatment: 1103 VAD