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

Model Number 1420

Device Problems Device Inoperable (1663); Connection Problem (2900)

Patient Problem Loss of consciousness (2418)

Event Date 03/29/2018

Event Type  Injury  

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.Concomitant product(s): a 419588 lead, 7122q65 lead, and cd3231-40q icd implanted on: (b)(6) 2011 other devices involved in this event: heartware ventricular assist system ¿battery.Battery / (b)(4), model #: 1650de / expiration date: 2018-07-31 udi #: (b)(4).Mfg date: 2017-07-31.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the ventricular assist device (vad) controller exhibited no power and poor mechanical connection and a battery exhibited no power.The patient was unconscious for approximately ten minutes and cardiopulmonary resuscitation was performed.The patient was reattached to a new controller and power source and intubated.The controller was exchanged and the battery remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller was returned for evaluation.The battery was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned controller in relation to the reported event.Failure analysis of the returned controller revealed that the unit passed functional testing; the controller was able to adequately connect to a battery on both power ports.As a result, the reported poor mechanical connection could not be confirmed.Visual inspection under 10x magnification revealed hairline cracks around power port one (1) and power port two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are additional observations unrelated to the reported event.Based on an internal investigation, the root cause of the hairline cracks 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.Log file analysis revealed a controller power up event on (b)(6) 2018, at 16:05:38.Several momentary disconnections were recorded leading up to the loss of power.The controller was without power for 6 minutes and 42 seconds.As a result, the loss of power event was confirmed.The reported inability of the battery to provide power could not be confirmed as the device was not returned for analysis.Applicable risk documentation and experience with events of similar circumstances were considered; events involving a battery not providing power can be attributed, but not limited, to a damaged battery connector, an internal battery communication error, a faulty integrated circuit, improper weld, and/or due to a soldering defect.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.An internal investigation was initiated to capture events involving the controller losing power.An internal investigation evaluated momentary disconnections.This event was assessed and is being reported as part of a retrospective review of log file data.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

Product event summary: the controller, (b)(4), was returned for evaluation.The battery (b)(4) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the controller in relation to the reported event.Failure analysis revealed that the returned controller passed functional testing.Visual inspection under 10x magnification revealed hairline cracks surrounding power port 1 and power port 2.An internal visual inspection did not reveal fluid ingress.The hairline cracks finding is not related to the reported event.Based on an investigation, the root cause of the hairline cracks 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.Additionally, the controller was able to adequately connect to a battery on both ports.As a result, the reported poor mechanical connection event could not be confirmed.Log file analysis revealed a controller power up event on (b)(6) 2018, at 16:05:38.The data point prior to the loss of power revealed that a battery was connected to power port one (1) with 91% relative state of charge (rsoc) and (b)(4) was connected to power port two (2) with 67% rsoc.The data point recorded after the loss of power revealed that a battery was connected to power port (1) and (b)(4) was connected to power port two (2).The controller was without power for 6 minutes.As a result, the loss of power event was confirmed.A possible root cause of the loss of power can be attributed to an intermittent disconnection on both power sources.The reported battery with no power event could not be confirmed as the unit was not returned for analysis.Applicable risk documentation and experience with batteries unable to provide power were considered; a possible root cause can be attributed, but not limited, to an internal battery communication error, a faulty integrated circuit, improper weld and/or due to a soldering defect.(b)(4), 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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7462665
• MDR Text Key: 106587466
• Report Number: 3007042319-2018-01599
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000475
• UDI-Public: 00888707000475
• 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
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• 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: 04/18/2018
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0067-2019
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR