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

Model Number 1103

Device Problems Increase in Suction (1604); Power Problem (3010); Pumping Problem (3016)

Patient Problems Dehydration (1807); Fall (1848); Tachycardia (2095); Loss of consciousness (2418)

Event Date 02/06/2022

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) patient was admitted to the hospital due to a fall with loss of consciousness after hitting their head.The patient was not very responsive when emergency medical services (ems) arrived.Upon arrival to the emergency department the patient was in ventricular tachycardia (vt) and required cardioversion.Five days later the patient was stable and discharged home.It is unclear as to what caused vt however dehydration and suction were suspected.It was also noted that there were low flow alarms and a loss of power to the controller.The controller remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Additional products: brand name: heartware ventricular assist system: controller.Model #: 1420, catalog #: 1420, expiration date: 28-feb-2021, 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: 12-feb-2020, 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.

Manufacturer Narrative

### a supplemental report is being submitted for a correction to h10 added the additional product and fda codes.Additional products: d4: serial#: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): 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.

Manufacturer Narrative

### a supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) (b)(6) and one controller (b)(6) were not returned for evaluation.Review of the controller log files revealed an intermittent suction event was logged on (b)(6) 2022 and five low flow alarms were logged on (b)(6) 2022.Log file analysis revealed a controller power up event with an associated pump start event logged on (b)(6) 2022 at 08:47:51.The data point prior to the loss of power revealed that an active adapter was connected to power port one and (b)(6) was connected to power port two with 94% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port one and (b)(6) was connected to power port two.No anomalies were observed leading up to the loss of power.The controller was without power for 14 seconds.As a result, the reported low flow, suction, and loss of power events were confirmed.Information received from the site indicated that the patient was admitted to the hospital due to a fall with loss of consciousness after hitting their head.The patient was not very responsive when emergency medical services (ems) arrived.Upon arrival to the emergency department the patient was in ventricular tachycardia (vt) and required cardioversion.Five days later the patient was stable and discharged home.It is unclear as to what caused vt however dehydration and suction were suspected.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow and suction events 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.A possible root cause of the loss 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.Per the instructions for use, cardiac arrhythmia is a known potential complication associated with the implantation of a vad.There was no evidence that the patient had a history of cardiac arrhythmia.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.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: 13685517
• MDR Text Key: 290289077
• Report Number: 3007042319-2022-02869
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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,Followup
• Report Date: 05/11/2022

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: 10/31/2020
• 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: 02/22/2022
• Initial Date FDA Received: 03/07/2022
• Supplement Dates Manufacturer Received: 05/11/2022; 05/11/2022
• Supplement Dates FDA Received: 05/11/2022; 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 94 KG