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

Model Number 1420

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Use of Device Problem (1670); Power Problem (3010)

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

Event Date 05/23/2019

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.Concomitant medical products: 1103 vad implanted: (b)(6) 2014.Additional products: heartware ventricular assist system ¿ battery model #: 1650de / catalog #: 1650de / expiration date: 31-aug-2019 / serial or lot#: (b)(4).Udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 22-aug-2018.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery model #: 1650de / catalog #: 1650de / expiration date: 31-aug-2019 / serial or lot#: (b)(4).Udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 22-aug-2018.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that two batteries had a relative state of charge with a communication error and a controller had an unexpected power loss.The batteries and controller are still in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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 further reported the controller had a double disconnect and loose power ports.The patient was reported to have heard associated alarms.

Manufacturer Narrative

Product event summary: the controller and two batteries were not returned for evaluation.Log file analysis revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Log file analysis revealed multiple controller power up and associated motor start events between (b)(6) 2019 and (b)(6) 2019.Several momentary disconnections involving the batteries were recorded leading up to the loss of power.There is no evidence that the lubrication servicing was performed on the reported devices.Furthermore, several relative state of charge (rsoc) values out of range due to communication errors were logged for both batteries.As a result, the reported rsoc with a communication error and losses of power were confirmed.However, the reported loose power ports could not be confirmed as the controller was not returned for analysis.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of loose power port connectors may be attributed to an inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.A possible root cause of the losses of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one both power sources.An internal investigation evaluated the ability to capture events involving the controller losing power.An internal investigation also evaluated momentary disconnections.The most likely root cause of the reported rsoc values between 101-201 can be attributed to communication errors between the controller and batteries.Possible root causes of the communication errors can be attributed to momentary disconnections on the communication pins of the controller, the controller not receiving responses from the battery, and/or due to the packet error checking method detecting bit errors.Additional products: d4: model #: (b)(6).H3: yes.H6: fda method code(s): 4112, 4114.H6: fda results code(s): 3213.H6: fda conclusion code(s): 4307, 12.Additional products: d4: model #: (b)(6).H3: yes.H6: fda method code(s): 4112, 4114.H6: fda results code(s): 3213.H6: fda conclusion code(s): 4307, 12.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.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 (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8728416
• MDR Text Key: 210635684
• Report Number: 3007042319-2019-07442
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: DVBC3D4 ICD, 6947M62 LEAD
• Patient Age: 21 YR