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

Model Number 1103

Device Problems Loss of Power (1475); Pumping Problem (3016)

Patient Problems Loss of consciousness (2418); Syncope/Fainting (4411)

Event Date 09/22/2021

Event Type  Death  

Manufacturer Narrative

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 patient was found lying unconscious in bed with no pulse.The ventricular assist device (vad) was alarming low flow.The emergency medical services (ems) was called and the patient was pronounced dead.An autopsy was not performed and a cause of death was not provided.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion and additional information b5.Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation.Two (2) controllers (b)(6) and five (5) batteries (b)(6) were returned for evaluation.No performance allegations were made against the returned controllers and batteries.Failure analysis of the returned controllers and batteries revealed that the devices passed visual inspection and functional testing.Of note, it was observed that the battery (b)(6) had exceeded the useful operating life of 500 charge and discharge cycles.This is an additional finding not related to the reported event and can be attributed to the battery reaching the end of its useful life.Review of the controller log files associated with (b)(6) revealed that the controller was not in use during the reported event date and was likely being used as a back-up controller.Log file analysis revealed that (b)(6) was the patient's primary controller, in use during the reported event.Review of the controller log files revealed associated with (b)(6) revealed four (4) controller power up events with associated pump start events logged on (b)(6) 2021 at 19:55:09, on (b)(6) 2021 at 20:20:36, and on (b)(6) 2021 at 13:31:05 and 14:09:49.No anomalies were logged prior to the losses of power.The controller was off 1 minute and 26 seconds, 11 seconds, 9 minutes and 7 seconds, and 2 minutes and 9 seconds, respectively.Log file analysis also revealed a gradual decrease in power consumption and estimated flows on (b)(6) 2021 beginning at 14:01:45, leading to parameters below normal operating range.Two (2) low flow alarms were logged on (b)(6) 2021 and four (4) low flow alarms were logged on (b)(6) 2021 between 13:32:20 and 14: 10:01.As a result, the reported low flow event was confirmed.Information received from the site indicated that, in addition to the low flow event, the patient was found lying unconscious in bed with no pulse.The emergency medical services (ems) was called and the patient was pronounced dead.An autopsy was not performed and a cause of death was not provided.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, death is known potential complication associated with the implantation of a vad.A possible root cause of the observed losses of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa: pr00551638 is investigating controller losses of power.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to poor vad filling, thrombus at the inflow cannula/outflow graft, and/or constriction at the outflow graft.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.D1: heartware ventricular assist system - controller 2.0 d4: model#: 1420-controller/ catalog#: 1420-controller / expiration date: 30-jun-2021 / serial or lot#: (b)(6); udi#: (b)(4); d10: yes, return date:.1-dec-2021; h3: yes dev rtn to mfr? yes; h4: mfg date: 07-jun-2020; h5: no; h6: patient ime code(s): e0119, e011903 h6: imf code(s): f02 h6: img code(s): g04035 h6: fda device code(s): a191002 h6: fda method code(s): b04, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d15 an internal investigation is pending.A report will be sent when root cause for the internal investigation has been determined.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.

Event Description

It was further reported that one controller was returned to the manufacturer and subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.

• 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: 12667530
• MDR Text Key: 277505151
• Report Number: 3007042319-2021-07726
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/28/2022
• Date Device Manufactured: 01/18/2018
• 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): Death
• Patient Age: 62 YR
• Patient Sex: Male