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

Model Number 1103

Device Problems Battery Problem (2885); Pumping Problem (3016)

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

Event Date 02/18/2024

Event Type  malfunction  

Event Description

It was reported that during log file review it was noted that the ventricular assist device (vad) exhibited low flow alarms and the controller exhibited a controller fault alarm due to internal battery end of life.  it was noted that the patient did not report the alarms when they occurred and had no signs or symptoms.  the vad remains in use and the controller was exchanged.  no patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Continuation d10: 5076-45, 6935m55 leads <(>&<)> ddmb1d4 icd implant date: (b)(6) 2018 additional products: d1: heartware ventricular assist system - controller 2.0 d4: model#: 1420 / catalog#: 1420 / expiration date: 30-nov-2019 / serial#: (b)(6) and udi#: (b)(4).D9: no h4: mfg date: 09-nov-2018 h5: 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.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Additional products: d4: serial or lot#: (b)(6) h3: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.Product event summary: the pump (b)(6) and the controller (b)(6) were not returned for evaluation.Log file analysis revealed a controller fault alarm was logged on 18/feb/2024 at 15:57:28 and multiple event exceptions were 18/feb/2024, indicating an issue with internal battery.In addition, log files revealed that the controller had been in use for more than two (2) years.Review of the alarm log file revealed three (3) low flow alarms were logged since 10/feb/2024.Review of the available autologs report revealed one (1) vad disconnect alarm was logged involving (b)(6) on 18/feb/2024 at 19:45:06, likely in powering up the controller in preparation for the controller exchange.As a result, the reported controller fault alarm and low flow events were confirmed.Based on the available information, the device may have caused or contributed to the reported low flow event.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, poor vad filling, and/or inappropriate pump rotational speed.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; a possible root cause of the reported controller fault alarm event may be attributed, but not limited, to a reduced charge capacity of the internal battery and/or a faulty internal battery charger integrated circuit.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18790034
• MDR Text Key: 336351536
• Report Number: 3007042319-2024-01093
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2019
• 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
• Treatment: 1103 VAD
• Patient Age: 59 YR
• Patient Sex: Female