HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
|
Back to Search Results |
|
Model Number 1104 |
Device Problem
Increase in Suction (1604)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/22/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding the intervention taken and log files, but it 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.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 frequent suction alarms.It was further reported that the cause was thought to be due to residual cardiac function or posture.Mean arterial pressure was managed at 80 mmhg or lower and the vad flow was sufficiently high despite high pulsatility.Of note, upon vad implant the patient had cardiac enlargement and the pump was fixated to the chest wall.The vad remains in use.No patient complications have been reported as a result of this event.
|
|
Event Description
|
It was further reported that fluid replacement was performed.
|
|
Manufacturer Narrative
|
A supplemental report is being submitted for additional event details.The event description, the annex f coding, the outcome at tributed to adverse event has been updated.Investigation of this event is pending and a supplemental report will be sent upon its completion.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 investigation summary.Product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.The reported suction event was confirmed through review of the available autologs report which revealed 120 suction alarms logged since (b)(6) 2021.Information provided by the site indicated that the ventricular assist device (vad) exhibited frequent suction alarms, which were thought to be due to residual cardiac function or posture.Mean arterial pressure was managed at 80 mmhg or lower and the vad flow was sufficiently high despite high pulsatility.Of note, upon vad implant the patient had cardiac enlargement and the pump was fixated to the chest wall.It was further reported that fluid replacement was performed.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 thrombus at the inflow cannula, poor vad filling, inappropriate pump rotational speed, and/or inappropriate positioning of the pump.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 correction.The patient did not require hospitalization for this event, remove the imf for hospitalization code and uncheck the patient outcome hospitalization.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.
|
|
Search Alerts/Recalls
|
|
|