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

Model Number 1103

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2022

Event Type  malfunction  

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-jun-2021 / serial #: (b)(4); udi #: (b)(4); device evaluated: no.No, device evaluation anticipated, but not yet begun.Mfg date: 16-jun-2020 labeled for single use: no.Additional products: heartware ventricular assist system battery; model #: 1650/ catalog #: 1650/ expiration date: 30-nov-2022 / serial #: (b)(4) udi #: (b)(4) device evaluated: no; no, device evaluation anticipated, but not yet begun mfg date: 18-nov-2021 labeled for single use: no.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was a controller power-up and motor start.The patient stated the controller had a battery in port 2 of the controller while exchanging the battery in port 1, but the controller and pump powered down during the exchange.On the logs the ventricular assist device (vad) was off for 19 seconds.The controller and the vad remains in use, the battery was replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental is being submitted for additional information.Additional products: (b)(6)- controller 2.0 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d15 (b)(6)¿ battery h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 product event summary: one (1) battery ((b)(6)) was returned for evaluation.One (1) pump ((b)(6)) and one (1) controller ((b)(6)) were not returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned battery revealed that the device passed visual inspection and functional testing.Log file analysis revealed a controller power-up event, with an associated motor start event, logged on 16-jul-2022 at 20:09:26.The data point recorded prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 69% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 24% rsoc.The data point recorded after the loss of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two (2).The controller was without power for 19 seconds.No anomalies were recorded leading up to the loss of power.As a result, the reported controller loss of power event was confirmed.However, the reported battery malfunction event was not confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on the one connected power source.Capa pr00551638 is investigating controller losses of power.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 a correction.(b)(6) d9 return date and h3 device return to manufacturer were updated.Additional products: serial #: (b)(6) d9: yes, return date: 03-aug-2022 h3: dev rtn to mfr? yes 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 battery was the culprit for the loss of power.

Manufacturer Narrative

A supplemental report is being submitted for additional event details and a correction.B5 describe event or problem and d6a implant date was updated.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.

• 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: 15095452
• MDR Text Key: 301754819
• Report Number: 3007042319-2022-06701
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2020
• 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: ICD:DVFB1D4, LEAD:6935M62
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 105 KG