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

Model Number 1103

Device Problems Disconnection (1171); Failure to Pump (1502); Pumping Stopped (1503); Power Problem (3010)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system controller 2.0 model #: 1420 / catalog #: 1420, expiration date: 31-jan-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 31-jan-2018.Labeled for single use: no (b)(4).Heartware ventricular assist system controller 2.0: model #: 1420 / catalog #: 1420.Expiration date: 30-nov-2019 / serial #: (b)(4).Udi #: (b)(4).Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun.Mfg date: 15-nov-2018.Labeled for single use: no.(b)(4).Additional information has been requested regarding the vad disposition of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the ventricular assist device (vad) patient accidently double disconnected their power sources on the controller.The patient was able to restore power but shortly after the controller exhibited a vad stop alarm.The patient exchanged their primary controller to the spare controller and the vad would run for a few minutes and the vad stop alarm reoccurred.On their way to the hospital, the patient was swapping between controllers, each time one alarmed, and despite repeated attempts to power cycle the vad between the primary and back up controller, the vad would not come up to speed or remain on.It was seen that the controller also exhibited multiple unexpected power losses.Upon admission to the intensive care unit (icu), the patient started to exhibit worsening heart failure symptoms and was started on inotropes, and the ejection fraction of the heart was noted to be at thirty percent (30%).The patient was transported to another hospital and is currently waiting for a heart transplant.The vad remains in the patient but the driveline was cut, and the controllers were removed from use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This supplemental is being submitted as a correction.The event description was updated to state the patient was intubated for r espiratory dysfunction.Ime codes were also corrected.Additional products: con319073 h6: patient ime code(s): e0743 con404473 h6: patient ime code(s): e0743 investigation of this event is pending and a supplemental report will be sent upon its completion.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.

Event Description

It was further reported that the patient had been intubated due to respiratory dysfunction.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation product event summary: the ventricular assist device (vad) and one controller ( (b)(6) ) were not returned for evaluation.One controller ((b)(6)) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Failure analysis of the returned controller revealed visual inspection and functional testing.Log file analysis revealed that (b)(6) was the patient¿s primary controller.Log file analysis pertaining to (b)(6) also revealed a first controller power up event logged on (b)(6) 2021 at 08:11:32.The data point recorded prior to the loss of power revealed that a power adapter was connected to power port one and (b)(6) was connected to power port two with 73% relative state of charge (rsoc).The data point recorded after the loss of power revealed that (b)(6) was connected to power port one and (b)(6) was connected to power port two.No anomalies were recorded leading up to the initial loss of power.The controller was without power for 6 seconds.A vad stopped alarm was then logged at 08:12:33, indicating that the pump failed to restart after several attempts.Additionally, fourteen (14) vad disconnect alarms, sixteen controller power up events due to troubleshooting of the controller and/or the reported controller exchanges.Eight (8) additional vad stopped alarms were logged due to failures of the pump to restart after multiple attempts.Log file analysis pertaining to (b)(6) revealed nine vad disconnect alarms due a physical disconnection of the driveline and thirty-two vad stopped alarms were logged on (b)(6) 2021 due to failures of the pump to restart after multiple attempts.Log file analysis pertaining to (b)(6) also revealed a controller power up event logged on (b)(6) 2021 at 09:15:13.Review of the event log file revealed that, prior to the power up event, the controller last had power on (b)(6) 2020.Additionally, review of t he data log file revealed that the controller was not in use prior to the controller power up event; the first data point with the pump connected since (b)(6) 2020 was logged on (b)(6) 2021 at 09:15:46, indicating that the power up event and the vad disconnect alarm occurred during a controller exchange.A vad stopped alarm was logged at 09:15:45, indicating that the pump failed to restart after several attempts.This was followed by additional controller power up events and vad disconnects until 10:51:28 likely due to the reported controller exchanges and/or to troubleshooting of the controller.Additional vad stopped alarms were recorded due to failures of the pump to restart after multiple attempts.As a result, the reported events were confirmed.Information received from the patient indicated that the patient started to exhibit worsening heart failure symptoms and was started on inotropes.The ejection fraction of the heart was noted to be at thirty percent (30%).It was further reported that the patient had been intubated due to respiratory dysfunction.Per the instructions for use, neurological dysfunction is a known potential complication associated with the implantation of a vad.There is no evidence that the patient had a history of neurological dysfunction events.(b)(6) is not in scope of fca cvg-21-q3-21.The most likely root cause of the initial controller loss of power can be attributed to the reported disconnection of both power sources from the controller as described in the event details.Based on the available information, the most likely root cause of the vad disconnect alarms and remaining controller power up events can be attributed to the reported controller exchanges.A possible root cause of the vad stopped alarms can be attributed to a failure of the pump to restart after several attempts.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: (b)(6) d10: yes, return date: 15-mar-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g04035.H6: fda method code(s): b01, b15.H6: fda results code(s): c19 h6: fda conclusion code(s): d12, d10; (b)(6) h3: yes h6: img code(s): g04035 h6: fda method code(s): b15, b17 h6: fda results code(s): c23, c19 h6: fda conclusion code(s): d10, d11, d12.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 - PUMP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 11455756
• MDR Text Key: 250906357
• Report Number: 3007042319-2021-01906
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/14/2021; 07/16/2021
• Supplement Dates FDA Received: 04/16/2021; 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0946-2021
• Patient Sequence Number: 1
• Treatment: 6935M55 LEAD, DVFB1D4 ICD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR