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

Model Number 1104

Device Problems Failure to Pump (1502); Battery Problem (2885)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420-controller/ catalog #:1420-controller / expiration date: 29-feb-2020 / serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, device mfg date: 07-feb-2019, labeled for single use: no.Additional information has been requested for type of pump failure and if there is controller fault alarms 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller had a depleting internal battery and the ventricular assist device (vad) was failing to restart.The controller was exchanged and the vad remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This supplemental is being submitted for completed investigation.Product event summary: the pump and controller were not returned for evaluation.Review of controller log files was not performed since log files were not available for analysis.As a result, the reported event could not be confirmed.Of note, it was further reported that the pump did not fail to restart; the controller exchange was performed in a controlled environment due to the possibility of the pump failing to restart, but the pump did not experience any issue following the controller exchange.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; a possible root cause of the reported controller depleting internal battery event can be attributed, but not limited, to a reduced charge capacity of the internal battery over time.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 29-feb-2020 / serial #: (b)(6) udi #: (b)(4) d9: no h4: mfg date: 07-feb-2019 h5: no h6: fda method code(s): b17 h6: fda results code(s): c20 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.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

This supplemental is being submitted for additional information.The event description in b5 was updated to reflect that the controller was not exchanged and in fact remains with the patient.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.

Event Description

It was further reported that the controller remains in use.

Event Description

It was further reported that the vad was not failing to restart.The controller was prophylactically exchanged because the battery was expected to deplete soon.There were no allegations against the vad or the controller.

Manufacturer Narrative

A supplemental report is being submitted for a correction.B5 was corrected to indicate that the vad was not failing to restart.The controller was prophylactically exchanged because the battery was expected to deplete soon.There were no allegations against the vad or the controller.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
• MDR Report Key: 11348130
• MDR Text Key: 232560125
• Report Number: 3007042319-2021-01650
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1