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

Model Number 1104

Device Problems Loose or Intermittent Connection (1371); Failure to Pump (1502); Pumping Stopped (1503)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2022

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) did not restart.The patient had called because the battery port of the con troller was out of place.The controller was exchanged with the back up controller and then the pump stopped alarm occurred, and the controller was immediately exchanged with a new controller but the same alarm occurred again.Afterwards, the same alarm occurred even though the vad was commanded to start again from the monitor.The patient was hemodynamically stable and his general condition was "well" under follow up.The vad remains implanted.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.Brand name: heartware ventricular assist system ¿ controller; device available for evaluation: no; device evaluated by mfr: no, device evaluation anticipated, but not yet begun; labeled for single use: no; patient ime code(s):(b)(4).Additional information has been requested regarding the controller serial numbers, 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.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 patient was hospitalized in the intensive care unit (icu).

Manufacturer Narrative

A supplemental report is being submitted as additional information has being received for this event.Updated section: b1:adverse event or product b5:desc evt problem h1:type of reportable event h6:patient ime code(s), h6: imf code(s) updated additional product: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #:1420/ catalog #:1420/ expiration date: 31-oct-2020 / serial or lot#: (b)(6), udi #: (b)(4), h6: patient ime code(s): e2402 h6: imf code(s): f2203, f08, f12 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #:1420/ catalog #:1420/ expiration date: 31-oct-2020 / serial or lot#: (b)(6), udi #: (b)(4), h6: patient ime code(s): e2402 h6: imf code(s): f2203, f08, f12 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #:1420/ catalog #:1420/ expiration date: 31-oct-2020 / serial or lot#: (b)(6), udi #: (b)(4), h6: patient ime code(s): e2402 h6: imf code(s): f2203, f08, f12 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.

Manufacturer Narrative

A supplemental report is being submitted for device analysis.Product event summary: the pump ((b)(6)) and three (3) controllers ((b)(6)) were not returned for evaluation.A review of (b)(6) manufacturing documentation confirmed that the associated device met all requirements for release.The available data log file did not cover the reported event date.Review of the alarm log file associated with (b)(6) revealed three (3) vad disconnect alarms and five (5) vad stopped alarms were logged on (b)(6) 2022.The first vad disconnect alarm was logged on (b)(6) 2022 at 17:00:44 indicating a physical disconnection of the driveline from the controller, which corresponds with the reported controller exchange attempt.The vad disconnect alarm cleared at 17:01:04 indicating the driveline was reconnected to the controller.Likely due to the troubleshooting during the reported vad stopped alarm on the back up controller.A vad stopped alarm was then logged at 17:01:25 due to a failure of the pump to restart after several attempts.This vad stopped alarm was followed by additional vad disconnect alarms indicating a physical disconnection of the driveline, controller power up events, and additional vad stopped alarms due to a failure of the pump to restart after several attempts, logged between 17:01:57 and 17:11:43, likely due to troubleshooting.In addition, analysis of the event log file revealed multiple controller reset events logged on (b)(6) 2022 between 17:04:32 and 17:14:30.During the controller reset events, review of the alarm log file revealed instances that only one power source was connected to the controller during the attempted pump start event.Log files pertaining to (b)(6) were not available for analysis.As a result, the reported failure to restart events and vad stop alarms were confirmed.The reported ¿power port connector out of place" event could not be confirmed due to insufficient evidence.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported ¿power port connector out of place" event may be attributed, but not limited, to improper assembly.Capa pr00609659 is investigating controller resets during pump start.The most likely root cause of the vad disconnect alarms can be attributed to physical disconnections of the driveline from the controller during the reported controller exchange attempt and/or troubleshooting of the vad stopped alarms.The most likely root cause of the vad stopped alarms can be attributed to a failure of the pump to restart after several attempts.(b)(6) was not in scope of fca cvg-21-q3-21, which was initiated for pumps with failures to restart.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.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 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: 16034450
• MDR Text Key: 308464954
• Report Number: 3007042319-2022-08545
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Weight: 80 KG