MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problems Device Inoperable (1663); Date/Time-Related Software Problem (2582); Connection Problem (2900)

Patient Problems Cardiac Arrest (1762); Death (1802); Dizziness (2194)

Event Date 06/05/2018

Event Type  Death  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Other devices involved in this event: heartware ventricular assist system ¿ controller 2.0.Controller 2.0 / (b)(4) / model #: 1420 / expiration date: 2018-08-31.Udi #: (b)(4).Device evaluation anticipated, but not yet begun.Mfg date: 2017-08-31.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a transition from ac power to battery was being made for the patient who is densely hemiplegic.The patient ¿got dizzy¿ then ¿they started cardiopulmonary resuscitation (cpr)." the pump appeared to have been off for 26-41 minutes.Emergency medical services arrived during this period and connected the patient to their backup controller.The backup controller was intermittently or not functioning and the patient was switched to an emergency loaner with restoration of normal pump function.The patient was unresponsive, sedated and intubated.Both controllers had severe damage to both power connections, rendering them incapable of running the pump.Both of the controllers were exchanged.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the patient subsequently died.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: two controllers were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported events.Visual inspection of (b)(4) under 10x magnification revealed a hairline crack around power port 1 and 2.An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks were not related to the reported event.Based on an internal investigation, the root cause of the hairline crack was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Failure analysis of the (b)(4) also revealed bent pins within power port one and two (1 and 2) of the controller.(b)(4) passed functional testing after replacing the power ports; functional testing revealed that the controller was able to start and was able to sound the "no power" alarm when both power sources were disconnected.Failure analysis of (b)(4) revealed bent pins within power port one and two (1 and 2) of the controller.The bent pins would not allow a battery to properly connect to a controller.As a result, the reported poor mechanical connection event was confirmed.The most likely root cause of the reported event can be attributed to a misalignment between the power port and battery output connector.An internal investigation was opened to evaluate bent/damaged pins with controller 2.0.Log file analysis did not reveal any real time clock error for both controllers.As a result, the reported real time clock error event could not be confirmed.Log files analysis of controller ((b)(4)) revealed a controller power up event on (b)(6) 2018, at 08:30:02.The data point prior to the loss of power revealed that a battery was connected to power port one (1) with 27% relative state of charge (rsoc) and no power source was connected to power port two (2).The data point recorded after the loss of power revealed that no power source was connected to power port (1) and a battery was connected to power port two (2).The power down time was recorded at 22:18:40, on (b)(6) 2018.The backup controller ((b)(4)), however, was powered up at 21:36:18; multiple power up events were recorded afterwards, likely due to the bent pins found within both power ports of the controller.As a result, the reported power up events were confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources, inability to securely connect a power source due to bent pins within both power ports and/or to an intermittent disconnection on one or both power sources.An internal investigation was initiated to capture events involving the controller losing power.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.Additional products: controller 2.0 / (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the controller which was connected to the patient had a clock error and was off by one hour from current time.Log file interrogation and inspection performed by the vad engineer indicated that the power sources could not be connected due to severely damaged connections.In order to obtain the log files, they had to manipulate the broken connector to get temporary power.It was noted that the damage to both controllers was consistent with inappropriately forcing the power connections.

Manufacturer Narrative

This supplemental is based solely on the receipt of a 3500a report.Section f has been updated to reflect that report.F1 user facility f2 uf/importer report number: (b)(4).F3 user facility name/address (b)(6) medical center 22 south greene st.Baltimore, md 21201 f4 contact person: ashley mikhail f5 phone number: (b)(6), f6 date user facility became aware of event: unknown f7 type of report: initial f8 date of this report: jul-2018, f9 approximate age of device: 0 years f10 event problem codes: n/a f11 report sent to fda: n/a f12 location where event occurred: n/a f13 report sent to manufacturer: yes/ jul-2018 f14 manufacturer name and address mfr.Name: heartware, inc.Addr: 14400 nw 60th ave city: miami lakes state: fl.Zip: 33014.Other devices involved in this event: d1: heartware ventricular assist system ¿ controller 2.0, d4: controller 2.0 / (b)(4) / model #: 1420, d10: yes, return date: 2018-07-10.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 additional information.Additional information was received regarding the recall number.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 - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7655154
• MDR Text Key: 112901966
• Report Number: 3007042319-2018-02810
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1336-2021
• Patient Sequence Number: 1
• Treatment: 1103 VAD; 1103 VAD
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 98