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

Model Number 1103

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Connection Problem (2900)

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 09/10/2022

Event Type  Death  

Event Description

It was reported that the ventricular assist device (vad) patient was in a car accident and the driveline became disconnected from the controller.The controller exhibited multiple loss of power, vad stop and vad disconnect alarms.The controller , the power, data, and driveline ports appeared intact and without damage.The driveline was reconnected and multiple attempts were made to restart the pump, but the vad failed to restart.During the transport to the hospital, the patient arrested and passed away.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420, catalog #:1420, expiration date: 31-jan-2021, 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: 17-jan-2020.Labeled for single use: no.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 was at a family event and while stepping out of a car their controller dropped to the ground and the patient's driveline was inadvertently disconnected, resulting in the vad turning off.Emergency medical services (ems) intubated the patient and began the use of a lucas compression device.Three rounds of epinephrine and one intravenous (iv) bolus were given by ems.Resuscitation continued into the hospital setting and staff immediately attempted to connect the patient to two hospital-owned in-house backup controllers but the vad would still not restart.Upon arrival to the hospital emergency department, the pump had been off for approximately one (1) hour and there were several additional attempts to restart the device, likely by family and ems.Review of log file noted that prior to coming to the hospital, the driveline was repeatedly disconnected and reconnected, in an attempt to restart the vad.It appeared that the driveline was plugged in while the controller was on, but the vad failed to restart with a total of 9 separate attempts.It was also noted that there are multiple controller power ups and down, but it does not appear that the driveline was connected during this period.The patient was not a candidate for extracorporeal membrane oxygenation (ecmo) and passed away after unsuccessful resuscitation attempts.

Manufacturer Narrative

This supplemental is based solely on the receipt of a 3500a report.Section f has been updated to reflect that report.5b patient race, b5 describe event or problem, and h6 codes were updated.H10 additional manufacturer narrative was updated to capture two controllers.F1 user facility f2 uf/importer report number: 2100020000-2022-8008, f3 user facility name/address: (b)(6) medical center (b)(6), f4 contact person: (b)(6), f5 phone number: (b)(6), f6 date user facility became aware of the event: f7 type of report: initial f8 date of this report: -sep-2022 f9 approximate age of device: f10 event problem codes: f11 report sent to fda: f12 location where event occurred: hospital, other - emergency department f13 report sent to manufacturer: yes, -sep-2022 f14 manufacturer name and address mfr.Name: heartware inc.Addl: 14400 nw 60th ave city: miami lakes state: fl zip: 33014 additional products: d4: serial #: (b)(6), h6: imf code(s): f2303 h6: fda device code(s): a12 d1: heartware ventricular assist system ¿ controller d4: model #: unk / catalog #: unk / expiration date: unk / serial #: unk udi #: asku d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: unk h5: no h6: patient ime code(s): e0602, e0742 h6: imf code(s): f23, f2303, f2306, f02 h6: img code(s): g04035 h6: fda device code(s): a141204 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿ controller d4: model #: unk / catalog #: unk / expiration date: unk / serial #: unk udi #: asku d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: unk h5: no h6: patient ime code(s): e0602, e0742 h6: imf code(s): f23, f2303, f2306, f02 h6: img code(s): g04035 h6: fda device code(s): a141204 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding the controller serial numbers 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.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation and investigation completion.Product event summary: the pump (b)(6), one controller ((b)(6)), and two controllers with unknown serial numbers were not returned for evaluation.Controller log files pertaining to the unknown controllers were not available for analysis.Review of the controller log files associated with (b)(6) revealed a vad disconnect alarm logged on (b)(6) 2022 at 10:02:38, indicating a physical disconnection of the driveline from the controller, which corresponds with the reported drop event resulting in a driveline disconnection.The vad disconnect alarm cleared at 10:03:14, indicating that the driveline cable was connected to the controller.The three controller power up events were then logged between 10:03:35 and at 10:04:06, indicating a loss of power.The controller was without power for a total of 42 seconds.A vad stopped alarm was then logged at 10:04:24 due to a failure of the pump to restart after several attempts.This vad stopped alarm was followed by several additional controller power up events, additional vad stopped alarms indicating a failure of the pump to restart after several attempts, and additional vad disconnect alarms due to a physical discon nection of the driveline from the controller, likely due to troubleshooting and the reported controller exchange.Review of the alarm log file associated with (b)(6) did not reveal any controller failed alarms logged within the analyzed period.As a result, the reported losses of power, vad disconnect alarms, and vad stopped alarms events were confirmed.The reported controller failed alarm and controller poor mechanical connection event could not be confirmed.In addition, review of the controller event file associated with (b)(6) revealed one event point recorded on (b)(6) 2022 after 11:25:59 with the date/time stamp of 31-feb-2099 at 00:00:00.The observed invalid date/time stamp event is an additional finding not related to the reported event.Further investigation using a representative sample revealed that the invalid date/time stamp event can be replicated when the controller is exposed to voltage spikes or noise caused when connecting a battery to the controller, resulting in a temporary loss of communication between the real time clock circuit and the user interface circuit (uic).The uic is responsible for operation of the controller, including recording data in the controller log files.Therefore, the loss of communication caused the controller to record an invalid date and time in the data log file.Based on the available information, the most likely root cause of the observed invalid date/time entry event can be attributed to a voltage spike or noise caused when connecting a battery to the controller.Based on the risk documentation, a possible root cause of the reported poor controller driveline connector poor mechanical connection event may be attributed, but not limited, to a damaged driveline connector and/or a marginal connection.The most likely root cause of the initial vad disconnect alarm event may be attributed to a physical disconnection of the driveline from the controller due to the reported dropping of the controller, as described in the event details.The most likely root cause of the controller drop event can be attributed to the handling of the device.The most likely root cause of the initial losses of power event can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr00551638 is investigating controller losses of power.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(6) was not in scope of (b)(4).Capa pr00532915 is investigating pump failures to restart outside the subpopulation of (b)(4).The most likely root cause of the remaining vad disconnect alarms and controller power up events can be attributed to the controller exchange and troubleshooting of the vad stopped alarms.Additional products: d4: serial #: (b)(6) h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19, c23 h6: fda conclusion code(s): d2,d10, d11,d15 h3: yes h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d14.H3: yes h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d14 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.

Manufacturer Narrative

A supplemental report is being submitted for additional event details.A4 weight in lbs.,a5a ethnicity,b5 describe event or problem, b7 relevant history and (b)(6).H6 codes were updated.G2 report source was updated with study.This information was received from the mechanical circulatory support product surveillance registry study.Additional products: d4: serial #: (b)(6).H6: fda device code(s):a07 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 dropped the vad bag getting out of the car.The vad was alarming ¿controller fail, change controller.".

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
• 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: 15411622
• MDR Text Key: 299784360
• Report Number: 3007042319-2022-07222
• 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: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• 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): Death
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White