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

Model Number 1104

Device Problems Increase in Suction (1604); Pumping Problem (3016)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/11/2022

Event Type  Injury  

Manufacturer Narrative

Additional products: brand name: heartware ventricular assist system ¿ controller 2.0 / model #: 1420 / catalog #: 1420 / expiration date: 31- aug-2020 / 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: 06-aug-2019 / labeled for single use: no / (b)(4).Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller had a controller fault alarm indicating end of internal battery life and the patient presented to the emergency room (er).Review of log files showed the ventricular assist device (vad) exhibited low flow and suction alarms.The controller fault alarm was muted, and the patient was prepped for a controller exchange the following day.A sheath was placed in the right femoral artery and right femoral vein just in case to prepare for the failure of the vad to restart when the controller was replaced.After the controller was replaced, the sheath was immediately removed.The vad remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) and the controller ((b)(6)) were not returned for evaluation.Log file analysis revealed two (2) suction alarms have been logged since (b)(6) 2022 and one (1) low flow alarm logged on (b)(6) 2022.Additionally, log file analysis revealed a controller fault alarm logged on (b)(6) 2022 at 22:48:32, indicating an issue with the internal battery.Log files also revealed that the controller was in use for more than two (2) years.As a result, the reported low flow, suction and controller fault alarm 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 and suction 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.Additional products: d4: serial #: (b)(6) h3: yes h6: img code(s): g04035 h6: fda method code(s): b15, b17 h6: fda results code(s): c02, c19 h6: fda conclusion code(s): d1105, d15 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: 14435025
• MDR Text Key: 292035415
• Report Number: 3007042319-2022-05136
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male