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

Model Number UNK-PUMP

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.This event was reported in the q1 2019 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.Additional devices: heartware ventricular assist system ¿ unknown controller model #: unknown / catalog #: unknown / expiration date: unk/ serial or lot#: unknown.Udi #: asku.Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ unknown controller model #: unknown / catalog #: unknown / expiration date: unk/ serial or lot#: unknown.Udi #: asku.Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ unknown controller model #: unknown / catalog #: unknown / expiration date: unk/ serial or lot#: unknown.Udi #: asku.Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ unknown controller model #: unknown / catalog #: unknown / expiration date: unk/ serial or lot#: unknown.Udi #: asku.Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ unknown controller model #: unknown / catalog #: unknown / expiration date: unk/ serial or lot#: unknown.Udi #: asku.Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ unknown controller model #: unknown / catalog #: unknown / expiration date: unk/ serial or lot#: unknown.Udi #: asku.Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's controller had a pump stop alarm just before boarding a flight.The alarms continued and the patient changed the controller 4 times.A healthcare professional changed the controller again when the patient was hospitalized and the ventricular assist device (vad) did not start right away and made a "grinding sound".Due to noncompliance this patient was not a candidate for transplant nor device exchange.The vad remains in use while the disposition of the controllers are unknown.No patient complications were reported as a result of the event.

Manufacturer Narrative

Product event summary: a pump with unknown serial number remains implanted and was not returned for evaluation.Six (6) controllers with unknown serial numbers were not returned for evaluation.The reported pump stop event and failure of the pump to restart were not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis.The reported grinding sound could not be confirmed due to insufficient evidence.Based on risk documentation, multiple factors may have contributed to the pump stop event including but not limited to thrombus within the device and/or a controller failure.Based on historical review of similar events, a possible cause of the failure of the pump to restart may be attributed, but not limited, to thrombus within the device and/or increased resistance due to patient physiology.Based on historical review of similar events, the reported grinding sound may be attributed to factors such as thrombus ingested within the pump.Additional products: unknown controller h6: fda conclusion code(s): 67 h6: fda method code(s): 4114 h6: fda results code(s): 3221 unknown controller h6: fda conclusion code(s): 67 h6: fda method code(s): 4114 h6: fda results code(s): 3221 unknown controller h6: fda conclusion code(s): 67 h6: fda method code(s): 4114 h6: fda results code(s): 3221 unknown controller h6: fda conclusion code(s): 67 h6: fda method code(s): 4114 h6: fda results code(s): 3221 unknown controller h6: fda conclusion code(s): 67 h6: fda method code(s): 4114 h6: fda results code(s): 3221 unknown controller h6: fda conclusion code(s): 67 h6: fda method code(s): 4114 h6: fda results code(s): 3221 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 ASSSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8843871
• MDR Text Key: 211456536
• Report Number: 3007042319-2019-08809
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-PUMP
• Device Catalogue Number: UNK-PUMP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 19 YR