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

Model Number 1420

Device Problems Disconnection (1171); Device Inoperable (1663); Device Displays Incorrect Message (2591); Connection Problem (2900); Power Problem (3010)

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

Event Date 03/01/2018

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 ¿ controller 2.0 / (b)(4)/ model #: 1420 / expiration date: 2018-06-30 udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun mfg date: 2017-06-30 (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was a double disconnect of power sources secondary to power switching issues of the controller.The patient indicated that there was inappropriate battery switching and power disconnect alarms although they were always connected to at least one power source.Initially, a battery was replaced but the patient reported more frequent and continued alarms after the battery exchange.Log files showed that there were two double power disconnects and subsequent pump stops secondary to no power.The patient¿s primary controller was exchanged and the power switching resolved.It was felt that the secondary controller may be faulty and was also exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Heartware ventricular assist system ¿ battery : battery / (b)(4)/ model #: 1650de / expiration date: 2018-06-30 udi #: (b)(4).Device not available for evaluation.Device evaluation anticipated, but not yet begun.Mfg date: 2017-06-30.Not labeled for single use.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the battery exhibited potential power switching that log files were unable to confirm.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).Battery: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Corrected section h6.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

Corrections: h6 product event summary: two controllers (con307071, con307305) and one battery (bat581606) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned controllers and battery revealed that the devices passed visual examination and functional testing.Log files analysis pertaining to con307305 revealed that the device was a backup controller.Log files analysis pertaining to con307071 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.Analysis of data files revealed premature power switching events due to momentary disconnections involving bat581606.Analysis of event files revealed 2 controller power ups and associated motor starts event on 01mar2018 at 22:57:13 and on 05mar2018 at 15:49:18.The controller was without power for 14 seconds in both instances.No anomalies were recorded before the first controller power up; however, multiple premature power switching events due to momentary disconnections were recorded before the second controller power up.As a result, the reported events were confirmed.The most likely root cause of the power switching events can be attributed to momentary disconnections.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 sources.Internal investigations were opened to evaluate momentary disconnections and to capture events involving the controller losing power.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

Section f of this supplemental is based solely on the receipt of a 3500a report and has been updated to reflect that report.F1 user facility f2 uf/importer report number: 2300380000-2018-8004 f3 user facility name/address spectrum health ¿ butterworth campus 100 michigan street ne grand rapids, mi 49503 f4 contact person: (b)(4).F5 phone number: 616-486-2522 f6 date user facility became aware of event: unknown f7 type of report: initial f8 date of this report: xx/apr/2018 f9 approximate age of device: n/a f10 event problem codes: n/a f11 report sent to fda: yes, xx/apr/2018 f12 location where event occurred: home f13 report sent to manufacturer: yes, xx/apr/2018 f14 manufacturer name and address: mfr.Name: medtronic addl: 710 medtronic pkwy city: minneapolis state: mn zip: 55432 controller 2.0 (b)(4).Product event summary: the controller passed visual inspection and functional testing.Investigation is ongoing.Additional products: controller 2.0 (b)(4).H3: yes h6 fda method code(s): 10, 23, 3372, 38 h6 fda results code(s): 213 h6 fda conclusion code(s): 71 product event summary: the controller passed visual inspection and functional testing.Investigation is ongoing.Battery (b)(4).D10: yes, return date: 2018-04-18 h3: yes h6 fda method code(s): 10, 23, 3372, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 product event summary: the returned battery passed visual inspection and functional testing.Investigation is ongoing.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.

Event Description

It was further reported the battery triggered two critical battery alarms following a controller upgrade.

• 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: 7386493
• MDR Text Key: 104138841
• Report Number: 3007042319-2018-01255
• 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,Followup,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: (B)(4).
• Patient Age: 69 YR
• Patient Weight: 104