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

Model Number 1103

Device Problems Date/Time-Related Software Problem (2582); Adverse Event Without Identified Device or Use Problem (2993); Power Problem (3010)

Patient Problem Tachycardia (2095)

Event Date 08/27/2021

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: esbf2814c103e stent graft, etlw1613c124e stent graft, etlw1620c124e stent graft, implanted (b)(6) 2019; 2187-85 lead, 694765 lead, implanted (b)(6) 2003; 407652 lead, 407658 lead, implanted (b)(6) 2008.Additional products: brand name: heartware ventricular assist system  controller 2.0, model #: 1420, catalog #: 1420, expiration date: 30-sep-2019, serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 18-sep-2018.Labeled for single use: no.(b)(4).Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller had an unexpected loss of power.The ventricular assist device (vad) patient subsequently experienced ventricular tachycardia - pulseless electrical activity (vt-pea) and died.

Event Description

It was further reported that an aide had entered the patient's room and heard an alarm which was presumed to be a no-power alarm.Of note, this occurred prior to the patient's death.

Manufacturer Narrative

A supplemental is being submitted for additional information.Additional information: - b5 desc evt problem - updated to include information regarding an alarm prior to patient's death.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.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

A supplemental report is being submitted for device evaluation and investigation completion.Product event summary: the ventricular assist device (vad) and the controller were not returned for evaluation.Log file analysis revealed a controller power up event, with an associated motor start event, on (b)(6)2021 at 22:03:20.The data point prior to the loss of power revealed that a battery was connected to power port one with 98% relative state of charge (rsoc) and a battery was connected to power port two with 82% rsoc.The data point recorded after the loss of power revealed that a battery was connected to power port one and no power source was connected to power port two.The controller was without power for 12 minutes and 18 seconds.Review of the alarm log file revealed 19 low flow alarms logged since (b)(6)2021 and one vad disconnect alarm logged on (b)(6) 2021 at 22:30:54, indicating a physical disconnection of the driveline from the controller.Review of the event log file revealed that the date/time on the controller was last manually set as (b)(6)2019 at 08:19:25; there were no observed anomalies regarding the date/time setting of the controller.As a result the reported controller incorrect time setting display could not be confirmed.The reported controller loss of power and "no power alarm" events were confirmed.Additional information received from the site indicated that the patient experienced ventricular tachycardia - pulseless electrical activity (vt-pea) and died; no additional information was available.Per the instructions for use, cardiac arrhythmias and death are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse events.A possible root cause of the loss of power can be attributed to a disconnection of both power sources.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or poor vad filling.The most likely root cause of the vad disconnect alarm can be attributed to a physical disconnection of the driveline from the controller.The most likely root cause of the reported incorrect controller time event can be attributed to an incorrect time being manually entered during the programming of the controller.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: d4: serial #: (b)(6)d10: no h3: yes h6: fda method code(s): b15,b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10,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 avenue; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12440326
• MDR Text Key: 270339083
• Report Number: 3007042319-2021-06245
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2021

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: 10/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 10/29/2021
• Supplement Dates FDA Received: 09/30/2021; 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: D314TRG ICD; D314TRG ICD
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male