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

Model Number 1103

Device Problems Increase in Suction (1604); Noise, Audible (3273)

Patient Problems High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567); Insufficient Information (4580)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

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 patient was admitted for a subtherapeutic international normalized ratio (inr) and elevated lactate dehydrogenase (ldh).It was noted that the pump sounded strange/off.A ramp echocardiogram was performed, and heparin drip was started while waiting for the inr to increase.Approximately two days later ldh decreased.The ventricular assist device (vad) remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Additional information was received regarding patient clinical symptoms.Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional event details were collected during a review of patient records with the healthcare facility.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that thrombus was suspected.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 evaluation.Product event summary: the vad was not returned for evaluation.Review of the controller log files revealed intermittent decreases in the estimated flow and power consumption starting 28/mar/2021, within the analyzed period.However, no low flow alarms have been logged within analyzed period.The reported pump "strange pump sound" event could not be confirmed due to insufficient evidence.Information received from the site revealed that the patient experienced subtherapeutic international normalized ratio (inr) and elevated lactate dehydrogenase (ldh).The patient was treated with heparin drip to increase the inr and a echocardiogram was performed.Two days later ldh decreased.Later, it was reported that the vad was explanted and the patient received a heart transplant.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Based on the risk documentation, possible causes of the observed low flow event may be attributed to multiple factors including but not limited to poor vad filling, thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or inappropriate pump rotational speed.Based on the risk documentation, the reported pump "strange pump sound" event may have been caused by pump vibration, which may be attributed to multiple factors including but not limited to thrombus within the device leading to impeller imbalance or the placement of the pump which allows contact with fixed or rigid anatomical structure.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.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

It was further reported that the vad was explanted and the patient received a heart transplant.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Additional information was received regarding further intervention provided as a result of the 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

A supplemental report is being submitted for an update to h10: product event summary.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Review of the controller log files revealed intermittent decreases in the estimated flow and power consumption starting (b)(6) 2021, within the analyzed period.However, no low flow alarms have been logged within analyzed period.The reported pump "strange pump sound" event could not be confirmed due to insufficient evidence.Information received from the site revealed that the patient experienced subtherapeutic international normalized ratio (inr) and elevated lactate dehydrogenase (ldh).The patient was treated with heparin drip to increase the inr and a echocardiogram was performed.Two days later ldh decreased.Additionally, the patient was suspected for thrombus.Later, it was reported that the vad was explanted, and the patient received a heart transplant.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Based on the risk documentation, possible causes of the observed low flow event may be attributed to multiple factors including but not limited to poor vad filling, thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or inappropriate pump rotational speed.Based on the risk documentation, the reported pump "strange pump sound" event may have been caused by pump vibration, which may be attributed to multiple factors including but not limited to thrombus within the device leading to impeller imbalance or the placement of the pump which allows contact with fixed or rigid anatomical structure.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Per the instructions for use, device thrombus is a known potential complication associated with the implantation of an vad.There was no evidence that the patient had a history of similar adverse events.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.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 a correction.B6 was updated with laboratory data.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 correction and update to the investigation.Correction b1: corrected from adverse event to adverse event and product problem correction b5: event description was corrected to include that the patient was euvolemic and there was suction.Correction h6: patient ime code was corrected to add e2320 and patient fdd code was updated to add a141302.Correction h10: updated investigation product event summary: the ventricular assist device (vad) was not returned for evaluation.The reported suction event was confirmed via review of the controller log files which revealed intermittent suction events starting since (b)(6)2021.However, no suction alarms have been logged within analyzed period.The reported pump "strange pump sound" or thrombus events could not be confirmed due to insufficient evidence.Information received from the site revealed that the patient experienced subtherapeutic international normalized ratio (inr) and elevated lactate dehydrogenase (ldh).The patient was treated with heparin drip to increase the inr and a echocardiogram was performed.Two days later ldh decreased.Additionally, the patient was suspected for thrombus.Later, it was reported that the vad was explanted and the patient received a heart transplant.It was further reported that the patient "was euvolemic and the suction has stopped so the thought is the patient was dry at the same time frame¿.Additional information indicates the pat ient had hypertension and blood pressure medication was adjusted giving the patient better control.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported suction event may be attributed to multiple factors including but not limited to poor vad filling, thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or inappropriate pump rotational speed.Based on the risk documentation, the reported pump "strange pump sound" event may have been caused by pump vibration, which may be attributed to multiple factors including but not limited to thrombus within the device leading to impeller imbalance or the placement of the pump which allows contact with fixed or rigid anatomical structure.Per the instructions for use, device thrombus and hypertension are known potential complications associated with the implantation of an vad.There was no evidence that the patient had a history of similar adverse events.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.This regulatory report is being submitted as part of a retrospective review and remediation per d00595825 due to an fda audit observation.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

It was further reported that the patient "was euvolemic and the suction has stopped so the thought is the patient was dry at the same time frame¿.Additional information indicates the patient had hypertension and blood pressure medication was adjusted giving the patient better control.

• 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: 11653097
• MDR Text Key: 245075530
• Report Number: 3007042319-2021-03167
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2020
• 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
• Treatment: DTMA1D4 ICD, 6935M55 LEAD, 457445 LEAD
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 88 KG