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

Model Number 1103

Device Problems Failure to Pump (1502); Battery Problem (2885); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Pulmonary Edema (2020); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2023

Event Type  Death  

Event Description

It was reported that the patient arrived at the clinic for a routine controller exchange due to controller fault internal battery end of life.It was stated that the site followed current protocol and performed the exchange with an ac power source and battery however, the ventricular assist device (vad) would not restart.The site attempted to restart the vad from the monitor but were unsuccessful.The patient was stable but was subsequently admitted to the intensive care unit (icu) where a surgical consult had been ordered.It was further reported that the patient expired the following day.

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: 30-nov-2021 / serial #: (b)(4), udi #: (b)(4), device available for manufacturer evaluation: no.Mfg date: 17-nov-2020.Adverse event problem: patient ime code(s): e2402; imf code(s): f02, f08, f0801; img code(s): g02002; fda device code(s): a0705; fda method code(s): b21; fda results code(s): c21; fda conclusion code(s): d16.Additional products: heartware ventricular assist system ¿controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 30-nov-2023/ serial #: (b)(4), udi #: (b)(4), device available for manufacturer evaluation: no.Mfg date: 01-nov-2022; patient ime code(s): e2402; imf code(s): f02, f08, f0801; img code(s): g04035; fda device code(s): a27; fda method code(s): b21; fda results code(s): c21; fda conclusion code(s): d16.Additional products: heartware ventricular assist system ¿cac adapter, model #: 1430 / catalog #: 1430/ expiration date: 30-apr-2024/ serial #: (b)(4), udi #: (b)(4), device available for manufacturer evaluation: no.Mfg date: 02-dec-2021.Device labeled for single use: no.; patient ime code(s): e2402; imf code(s): f02, f08, f0801; img code(s): g02027; fda device code(s): a27; fda method code(s): b21; fda results code(s): c21; fda conclusion code(s): d16.Additional products: heartware ventricular assist system ¿battery, model #: 1650 / catalog #: 1650 / device available for manufacturer evaluation: no.Device labeled for single use: no.Patient ime code(s): e2402; imf code(s): f02, f08, f0801; img code(s): g02002; fda device code(s): a0705 ; fda method code(s): b21; fda results code(s): c21; fda conclusion code(s): d16.Additional information has been requested regarding the details 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 further reported that the patient went into pulmonary edema in the intensive care unit (icu) and was intubated.The patient s ubsequently died from cardiac arrest.

Manufacturer Narrative

###a supplemental report is being submitted for additional event details and the receipt of a maude report.(b)(6) section f has been updated to reflect that report.Maude database report number: mw5115711.F1 user facility f2 uf/importer report number: mw5115711 f3 user facility name/address: (b)(6) 782297822 f4 contact person: (b)(6).F6 date user facility became aware of the event: f7 type of report: voluntary f8 date of this report: 10-mar-2023 f9 approximate age of device: f10 event problem codes: f11 report sent to fda: yes f12 location where event occurred: hospital f13 report sent to manufacturer: yes f14 manufacturer name and address mfr.Name: medtronic, plc addl: (b)(6) 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 a correction, updated additional product serial number.Additional products: d1: heartware ventricular assist system ¿ battery d4: model #: 1650/ catalog #: 1650/ expiration date: 31-dec-2023/ serial or lot#: (b)(6) udi #(b)(4).D9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 06-dec-2022 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.

Manufacturer Narrative

A supplemental report is being submitted for device analysis.Product event summary: the ventricular assist device (b)(6) and one (1) battery (b)(6) were not returned for evaluation.Two (2) controllers (b)(6) and one (1) controller ac adapter (b)(6) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of the returned devices revealed that the units passed visual inspection and functional testing.Internal inspection of the returned devices did not reveal any anomalies.Log file analysis revealed that (b)(6) was the patient¿s primary controller, initially in use during the reported event date.Analysis of the controller log files associated with (b)(6) revealed five (5) vad disconnect alarms and five (5) vad stopped alarms were logged on (b)(6) 2023.The initial vad disconnect alarm was recorded at 09:38:27 indicating a physical disconnection of the driveline from the controller, which correlates with the reported controller exchange event.A controller power up event was logged at (b)(6) 2023 at 09:40:40, likely due to the controller being powered up back to troubleshoot the reported failure to restart event involving (b)(6).Review of controller log files revealed that (b)(6) was connected along with a controller power source adapter.A vad stopped alarm was then logged at 09:41:07 indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by several additional vad disconnects indicating a physical disconnection of the driveline from the controller and vad stopped alarms indicating that the pump failed to restart after several attempts, likely due to troubleshooting.Log files associated with (b)(6) revealed a controller power up event, initial set up event, and vad disconnect alarm indicating that the driveline was not yet connected were logged on (b)(6) 2023.Log files associated with (b)(6) twenty (20) vad stopped alarms and seven (7) additional vad disconnect alarms were logged on (b)(6) 2023.A vad stopped alarm was recorded at 10:03:52, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional vad disconnect alarms indicating a physical disconnection of the driveline from the controller, vad stopped alarms indicating that the pump failed to restart after several attempts, and additional controller power up events, likely due to troubleshooting.Log files did not reveal any controller fault alarms logged within the analyzed period.As a result, the reported failure to restart event was confirmed.Controller log files did not reveal any controller fault alarms.As a result, the reported controller fault event could not be confirmed.The most likely root cause of the observed vad disconnect alarms can be attributed to physical disconnections of the driveline from the controller during the controller exchange and troubleshooting of the vad stopped alarms.(b)(6) was not in scope of fca cvg-21-q3-21.The most likely root cause of the vad stopped alarms can be attributed to a failure of the pump to restart after multiple attempts.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.Additional products: d4: serial or lot#: (b)(6) d9: yes, return date: 03-apr-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d4: serial or lot#: (b)(6) d9: yes, return date: 03-apr-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d4: serial or lot#: (b)(6) d9: yes, return date: 03-apr-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: serial or lot#: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 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.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: 16555179
• MDR Text Key: 311425722
• Report Number: 3007042319-2023-01196
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• 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: 56 YR
• Patient Sex: Female