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

Model Number 1103

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/18/2020

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested for confirmation/ treatment of the suspected vad ingestion as well as log files for analysis of the event.This information was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.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.

Event Description

It was reported that the ventricular assist device (vad) exhibited low flow alarms as well as high power and corresponding high watt alarms.It was further noted that a vad stop occurred with associated vad stop alarms.The controller was exchanged multiple times but the vad would not restart.It was suspected that there was an ingestion inside of the vad which prevented the impeller from spinning.The vad remains implanted but is out of service.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Review of the log files revealed a sudden decrease in power consumption on (b)(6) 2020, leading to parameters below the normal operating range, and a subsequent sharp rise in power consumption and estimated flows to levels above normal operating range.57 low flow alarms were logged since (b)(6) 2020 and two high watt alarms were logged on (b)(6) 2020 at 23:46:22 and 23:50:35.Additionally, one vad disconnect alarm was logged on (b)(6) 2020 at 01:48:38, indicating the physical disconnection of the driveline from the controller.A vad stopped alarm was then logged at 01:49:00, indicating that the vad failed to restart after multiple attempts.An additional vad disconnect alarm was logged at 02:11:39, likely during the reported controller exchange while troubleshooting.As a result, the reported events were confirmed.Based on the available information, there is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the historical review of similar high power events, the most likely root cause of the high power event may be attributed to external factors such as thrombus formation/ingestion.The low flows may be attributed to thrombus at the inflow cannula which likely got ingested into the vad, further triggering high watt alarms and subsequently resulting in a vad stop due to the thrombus preventing the vad from restarting.Per the vad instructions for use, device thrombus is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had previously experienced a thrombus event.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 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.

Manufacturer Narrative

Correction: b5, h10 a supplemental report is being submitted for a correction.B5 description of event problem corrected to include that the manufacturer received product performance data associated with this event.The controller subsequently tested out of specification during manufacturer's analysis.The controller was removed from service.H10 corrected to include additional product.Product event summary: the ventricular assist device (vad) and the controller were not returned for evaluation.Review of the controller log files revealed a sudden decrease in power consumption on (b)(6) 2020, leading to parameters below the normal operating range, and a subsequent sharp rise in power consumption and estimated flows to levels above normal operating range.57 low flow alarms were logged since (b)(6) 2020 and two high watt alarms were logged on (b)(6) 2020 at 23:46:22 and 23:50:35.Additionally, one vad disconnect alarm was logged on (b)(6) 2020 at 01:48:38, indicating the physical disconnection of the driveline from the controller.A vad stopped alarm was then logged at 01:49:00, indicating that the vad failed to restart after multiple attempts.An additional vad disconnect alarm was logged at 02:11:39, likely during the reported controller exchange while troubleshooting.As a result, the reported events were confirmed.Based on the available information, there is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the historical review of similar high power events, the most likely root cause of the high power event may be attributed to external factors such as thrombus formation/ingestion.The low flows may be attributed to thrombus at the inflow cannula which likely got ingested into the vad, further triggering high watt alarms and subsequently resulting in a vad stop due to the thrombus preventing the vad from restarting.Per the vad instructions for use, device thrombus is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had previously experienced a thrombus event.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 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: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: (b)(6) 2020 / serial #: (b)(6) udi #:00888707000475 ( d9: no h3: yes h4: mfg date: (b)(6) 2019 h5: no h6: patient ime code(s): e0514 h6: imf code(s): f1203 h6: fda device code(s): a141204 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 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.

Event Description

The manufacturer received product performance data associated with this event.The controller subsequently tested out of specification during manufacturer's analysis.The controller was removed from service.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Additional information was received regarding medical intervention.Additional products: d4: serial #: (b)(6), h6: imf code(s): f1903 investigation of this event is pending and a supplemental report will be sent upon its completion.The additional event details were collected during a review of patient records with the healthcare facility.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 that the vad was explanted due to suspected thrombus.The additional event details were collected during a review of patient records with the healthcare facility.

Manufacturer Narrative

A supplemental report is being submitted for device analysis.Product event summary: the ventricular assist device (vad) (b)(6) and one (1) controller ((b)(6)) were not returned for evaluation.Review of the controller log files revealed a sudden decrease in power consumption on (b)(6) 2020, leading to parameters below the normal operating range, and a subsequent sharp rise in power consumption and estimated flows to levels above normal operating range.57 low flow alarms were logged since (b)(6) 2020 and two (2) high watt alarms were logged on (b)(6) 2020 at 23:46:22 and 23:50:35.Additionally, one (1) vad disconnect alarm was logged on (b)(6) 2020 at 01:48:38, indicating the physical disconnection of the driveline from the controller.A vad stopped alarm was then logged at 01:49:00, indicating that the pump failed to restart after multiple attempts.An additional vad disconnect alarm was logged at 02:11:39, likely during the reported controller exchange while troubleshooting.As a result, the reported events were confirmed.Information received from the site indicated that an ingestion was suspected inside of the vad and the vad was taken out of service.Later the vad was explanted due to suspected thrombus.Based on the available information, the device may have caused or contributed to the reported event.Based on the historical review of similar high power events, the most likely root cause of the high power event may be attributed to external factors such as thrombus formation/ingestion.The low flows may be attributed to thrombus at the inflow cannula which likely got ingested into the pump, further triggering high watt alarms and subsequently resulting in a vad stop due to the thrombus preventing the pump from restarting.Per the instructions for use, device thrombus is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had previously experienced a thrombus event.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 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/DRIVELINE
• 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: 10713161
• MDR Text Key: 212348622
• Report Number: 3007042319-2020-06982
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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,Followup,Followup
• Report Date: 02/03/2022

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: 08/31/2019
• 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: 10/18/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 12/23/2020; 07/29/2021; 01/24/2022
• Supplement Dates FDA Received: 01/05/2021; 01/22/2021; 08/20/2021; 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male