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

Model Number 1103

Device Problems Electrical /Electronic Property Problem (1198); Pumping Problem (3016); Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

Patient Problems Dehydration (1807); Pain (1994); Burning Sensation (2146); Thrombosis/Thrombus (4440)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding the patient outcome and disposition of the device 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.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 reported that the patient presented with ventricular assist device (vad) low flow alarms.It was assumed that the patient was dry and was provided fluid bolus.Then, the pump exhibited high watts alarms and power consumption elevated to 25 watts.The pump heated up causing the patient pain and burning sensation.Coumadin and heparin drips were started at admission, and it appeared that the pump developed a thrombus which started as inflow and was ingested.It was noted that the patient¿s international normalized ratio (inr) was therapeutic at the time of the event.The patient was not a candidate for pump exchange or transplant.The pump was decommissioned.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental is being submitted for an update to: -b5.Desc evt problem 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.

Event Description

It was further reported that the patient is still alive.

Event Description

Two controllers were added to the event as they tested out of specification during manufacturer¿s analysis.

Manufacturer Narrative

A supplemental report is being submitted for investigation summary.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #:1420 / catalog #:1420 / expiration date:11-nov-2020 / serial or lot#: (b)(6), udi #: (b)(4), d9: no h3: yes h4: 19-nov-2019 h5: no h6: patient ime code(s): e0514, e1201, e1705, e2330 h6: imf code(s): f1203, f08, f23, f2303 h6: img code(s): g04035 h6: fda device code(s): a07 h6: fda method code(s): b15, b17 h6: fda results code(s): c02, c19 h6: fda conclusion code(s): d10, d02 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #:1420 / catalog #:1420 / expiration date:31-may-2021 / serial or lot#: (b)(6), udi #: (b)(4), d9: no h3: yes h4: 29-may-2020 h5: no h6: patient ime code(s): e0514, e1201, e1705, e2330 h6: imf code(s): f1203, f08, f23, f2303 h6: img code(s): g04035 h6: fda device code(s): a27 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 product event summary: the ventricular assist device (vad) ((b)(6)) and two (2) controllers ((b)(6)) were not returned for evaluation.No performance allegations were made against the controllers.Review of the controller log files associated with (b)(6) revealed a sudden decrease in power consumption and estimated flows on 18/jul/2022 leading to parameters below the normal operating range and a subsequent rise in power consumption and estimated flows to levels above normal operating range.Twelve (12) low flow alarms and eleven (11) high watt alarms were logged on 18/jul/2022.Review of the alarm log file associated with (b)(6) then revealed two (2) vad disconnect alarms and one (1) vad stopped alarm were logged on 18/jul/2022.The first vad disconnect alarm was logged on 18/jul/2022 at 21:21:19.An analysis of the alarm file revealed that this vad disconnect alarm was most likely a false alarm, given that the speed recorded at the onset of the alarm was higher than the set speed.This indicates that a possible loss of synchronization of commutation occurred.Commutation is the process of switching winding current to generate motion.If the pump rotational speed drifts higher than the speed set-point, the motor voltage will decrease to achieve the desired speed.However, if there is no change to the speed (speed reading remains frozen), the voltage will continue to decrease to zero.This likely caused the current to decrease to zero, triggering a vad disconnect alarm, even if the driveline was still physically connected to the controller.This was followed by a vad stopped alarm logged at 21:21:41, indicating that the pump failed to restart after multiple attempts.Additionally, a second vad disconnect alarm was at 21:23:07, indicating a physical disconnection of the driveline from the controller, likely due to troubleshooting and/or a controller exchange.Log file analysis associated with (b)(6)revealed two (2) controller power up events logged on 18/jul/2022 at 20:33:49, indicating that the controller was put into use following a controller exchange.Review of the alarm log file associated with (b)(6) then revealed one (1) vad stopped alarm logged on 18/jul/2022 at 20:33:49, indicating the vad failing to restart after multiple attempts.In addition, log file analysis revealed power consumption above 25 watts during the period in which the pump was attempting to restart.Information received from the site indicated that, in addition to the low flow and high power event, the patient was provided fluid bolus.The pump heated up causing the patient pain and burning sensation.Coumadin and heparin drips were started at admission, and it appeared that the pump developed a thrombus which started as inflow and was ingested.It was noted that the patient¿s international normalized ratio (inr) was therapeutic at the time of the event.The patient was not a candidate for pump exchange or transplant and the pump was decommissioned.The reported low flow and high power events were confirmed.The reported pump overheating event could not be confirmed due to insufficient evidence.Based on the available information, the device may have caused or contributed to the reported event.Possible causes of the vad disconnect alarms can be attributed to a loss of synchronization of commutation, leading to false vad disconnect alarms, and/or a physical disconnection of the driveline from the controller.Capa pr00550440 is investigating controller losses of synchronization of commutation.Based on historical review of similar events and the available information, the most likely root cause of the reported high power and pump overheating event can be attributed, but not limited to external factors such as thrombus formation/ingestion.Based on the available information, the most likely root cause of the low flow event may be attributed to thrombus at the inflow cannula.The thrombus likely got ingested into the pump resulting in an increase in power and triggering high watt alarms, further resulting in the observed vad stop event due to the thrombus preventing the pump from restarting.Per the instructions for use, device thrombus and death are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of thrombus.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.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
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15130443
• MDR Text Key: 296876245
• Report Number: 3007042319-2022-06753
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• 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
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 85 KG