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

Model Number 1104

Device Problem Failure to Pump (1502)

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

Event Date 08/27/2019

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

Event Description

It was reported that the ventricular assist device (vad) would not turn on during implant.The vad was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the hvad pump, two (2) controllers, and one (1) drive line extension cable were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the pump.Failure analysis of the returned controllers and drive line extension cable revealed that the devices passed visual examination and functional testing.Review of the controller log files revealed four (4) vad stopped alarms logged on (b)(6) 2019 between 11:39:26 and 11:47:05 due to failures of the pump to restart after several attempts.The alarms were logged on both controllers, which corresponds with the controller exchange described in the event description as an attempt to troubleshoot the alarm.As a result, the reported event was confirmed.Internal evaluation investigated failures of the pump to restart at the system level (interaction between the pump and peripheral devices).Based on an extensive investigation, the likely contributing cause for failure to restart was the inability of the pump-start algorithm to provide sufficient torque to overcome abnormally high mechanical resistance caused by unknown conditions that existed prior to the failed restart attempt.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Brand name: heartware ventricular assist system ¿ driveline extension cable, model #: unk / catalog #: unk / expiration date: unk / serial or lot#: unk udi #: asku concomitant medical products: yes, return date: (b)(6) 2019, device evaluated by mfr: yes dev ret to mfr?: yes.Mfg date: unk labeled for single use: no.Patient code(s): c76143, device code(s): c63165, fda method code(s): 10, fda results code(s): 213 h6 fda conclusion code(s): 67 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.

Event Description

It was further reported the driveline extension cable and two controllers that were used during the unsuccessful vad implant procedure were exchanged.

Manufacturer Narrative

Product event summary: the hvad pump and two (2) 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 event.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the pump or outflow graft.Failure analysis of the returned controllers revealed that the devices passed visual examination and functional testing.Review of the controller log files revealed four (4) vad stopped alarms logged on (b)(6) 2019 between 11:39:26 and 11:47:05 due to failures of the pump to restart after several attempts.The alarms were logged on both controllers, which corresponds with the controller exchange described in the event description as an attempt to troubleshoot the alarm.As a result, the reported event was confirmed.Internal evaluation investigated failures of the pump to restart at the system level (interaction between the pump and peripheral devices).Based on an extensive investigation conducted the likely contributing causes for failure to restart come from the presence of increased starting resistance in a very small number of implanted patients.This resistance is likely specific to the physiology of these patients, an area of limited access for further investigation.Therefore, no actionable root causes were identified.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-oct-2019 / serial or lot#: (b)(6).Udi #: (b)(4).D10: yes, return date: 11 sep 2019 h3: yes dev ret to mfr?: yes h4: mfg date: 31-oct-2018 h5: no h6: patient code(s): c76143 h6: device code(s): c139470 h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 4310 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-oct-2019 / serial or lot#: (b)(6).Udi #: (b)(4).D10: yes, return date: 11 sep 2019 h3: yes dev ret to mfr?: yes h4: mfg date: 31-oct-2018 h5: no h6: patient code(s): c76143 h6: device code(s): c139470 h6 fda method code(s): 10, 4112 h6 fda results code(s): 213 h6 fda conclusion code(s): 4310 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 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.

Manufacturer Narrative

A supplemental report is being submitted for device analysis.H6: the codes present in section h6 correspond to components/products that comprise the reported event.Product event summary: the hvad pump (b)(6), two (2) controllers (b)(6), and one (1) driveline extension cable (unknown lot number) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Failure analysis of the returned controllers and driveline extension cable revealed that the devices passed visual examination and functional testing.Review of the controller log files revealed four (4) vad stopped alarms logged on (b)(6) 2019 between 11:39:26 and 11:47:05 due to failures of the pump to restart after several attempts.The alarms were logged on both (b)(6), which corresponds with the controller exchange described in the event description as an attempt to troubleshoot the alarm.As a result, the reported event was confirmed.Based on an internal investigation conducted to investigate failures of the pump to restart at the system level (interaction between the pump and peripheral devices), the likely contributing cause for failure to restart was the inability of the pump-start algorithm to provide sufficient torque to overcome abnormally high mechanical resistance caused by unknown conditions that existed prior to the failed restart attempt.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: 8961626
• MDR Text Key: 156493375
• Report Number: 3007042319-2019-10754
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/08/2023

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 Expiration Date: 02/28/2021
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 11/14/2019; 12/11/2019; 12/12/2019; 02/04/2021; 08/07/2023
• Supplement Dates FDA Received: 11/18/2019; 12/11/2019; 12/13/2019; 02/22/2021; 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0946-2021
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 92 KG