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

Model Number 1104

Device Problems Battery Problem (2885); Pumping Problem (3016); Appropriate Term/Code Not Available (3191)

Patient Problems Lactate Dehydrogenase Increased (4567); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system ¿ controller d4: model #: 1420 / catalog #: 1420.Udi #: (b)(4) d9: no: h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.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 reported that the ventricular assist device (vad) exhibited numerous high watt alarms, and the patient experience elevated lactate dehydrogenase (ldh) after a controller exchange.The vad is included in the subgroup 3 population for delay or failure to restart.The vad remains in use, and the controller was exchanged.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) (b)(6) and one (1) controller with unknown serial number were not returned for evaluation.Log file analysis revealed intermittent increases in power consumption during the analyzed period.Thirty-two (32) high watt alarms were logged since 07/jan/2024.Review of the controller log files involving the controller with unknown serial number could not be performed since log files were not available for analysis.Based on the available information, the device may have caused or contributed to the reported high-power event.As a result, the reported high-power event was confirmed.The reported controller fault alarm could not be confirmed.Based on the risk documentation, possible causes of the reported high-power event may be attributed to multiple factors including but not limited to external factors such as thrombus formation/ingestion, inappropriate pump rotational speed, and/or patient related factors.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 nickel-metal hydride (nimh) battery and/or a faulty internal battery charger integrated circuit.Additional products: d1: controller d4: serial#: h3: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.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.

Event Description

It was further reported that the controller was exchanged due to internal depleted battery.

Manufacturer Narrative

A supplemental report is being submitted for additional information received.Updated b5, h6 and additional codes.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: 18686729
• MDR Text Key: 335141928
• Report Number: 3007042319-2024-00943
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Date Device Manufactured: 04/20/2020
• 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: "SEE H11...."
• Patient Outcome(s): Other