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

Model Number 1420

Device Problem Device Inoperable (1663)

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

Event Date 03/15/2018

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.Other devices involved in this event: heartware ventricular assist system ¿ battery, battery / (b)(4)/ model #: 1650 / expiration date: 2016-07-31, udi #: (b)(4), mfg date: 2015-07-31.(b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4)/ model #: 1650 / expiration date: 2016-07-31, udi #: (b)(4), mfg date: 2015-07-31, (b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2016-07-31, udi #: (b)(4), mfg date: 2015-07-31, (b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2016-07-31, udi #: (b)(4), mfg date: 2015-07-31.(b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2016-07-31, udi #: (b)(4), mfg date: 2015-07-31, (b)(4).Heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2016-07-31, udi #: (b)(4), mfg date: 2015-07-31, (b)(4).Heartware ventricular assist system ¿ patient pack, patient pack /asku/ model #: 1475 / expiration date: asku, udi #: (b)(4), mfg date: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient has had several pump stops due to loss of power to the controller.The patient indicated they have had issues with the battery connections due to physical barriers of the patient pack.The battery connections were inspected and seemed to be working appropriately with no significant physical damage.The controller and batteries remain in use.The patient pack was replaced with a shoulder pack.No patient complications have been reported as a result of this event.

Event Description

It was further reported that the patient pack has a velcro strap that wraps around the side of the pack.The strap is designed to go in between the battery connection and driveline or the battery connection and monitor connection, depending on what side of the patient pack is being viewed.The reported physical barriers of the patient pack causing battery connection issues was that the velcro strap was getting in the way of the battery connections.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

Manufacturer Narrative

Product event summary: the controller (b)(4), six batteries (b)(4) and a patient pack with unknown lot number were not returned for evaluation.Log file analysis revealed a controller power up event on (b)(6) 2018, at 16:21:24.The data point prior to the loss of power revealed that (b)(4) was connected to power port one (1) with 78% relative state of charge (rsoc) and (b)(4) was connected to power port two (2) with 98% (rsoc).The data point recorded after the loss of power revealed that (b)(4) was connected to power port (1) and an ac adapter was connected to power port two (2).No anomalies were recorded before the loss of power.The controller was without power for 13 seconds.As a result, the reported loss of power was confirmed.However, the reported "patient pack causing battery connection issues" event could not be confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power source.Other devices involved in this event: d1: heartware ventricular assist system ¿ battery serial number: (b)(4).H6 method code(s): 4112, 4114 h6 result code(s): 213 h6 conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial number: (b)(4).H6 method code(s): 4112, 4114 h6 result code(s): 213 h6 conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial number: (b)(4).H6 method code(s): 4112, 4114 h6 result code(s): 213 h6 conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial number: (b)(4).H6 method code(s): 4112, 4114 h6 result code(s): 213 h6 conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial number: (b)(4).H6 method code(s): 4112, 4114 h6 result code(s): 213 h6 conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial number: (b)(4).H6 method code(s): 4112, 4114 h6 result code(s): 213 h6 conclusion code(s): 67 d1: heartware ventricular assist system ¿ patient pack model #: 1475 h6 method code(s): 4114 h6 result code(s): 3221 h6 conclusion code(s): 67 medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: 7423239
• MDR Text Key: 105663570
• Report Number: 3007042319-2018-01419
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4).