|
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
|
Back to Search Results |
|
| Model Number 1103 |
| Device Problems
Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016); Noise, Audible (3273)
|
| Patient Problems
Loss of consciousness (2418); Thrombosis/Thrombus (4440)
|
| Event Date 09/07/2022 |
|
Event Type
Injury
|
|
Event Description
|
|
It was reported that the controller exhibited controller fault alarms due to a depleted internal battery and also exhibited unexpected losses of power.The patient was admitted for a controller exchanged under medical supervision.The controller was exchanged and the ventricular assist device (vad) stopped and failed to restart.The controller was exchanged back to the original controller and the vad did not restart immediately.The patient lost consciousness and cardiopulmonary resuscitation (cpr) was performed.Medication was initiated and the vad ramped up in speed and eventually restarted.Noise from the vad could be heard from the patient's chest.Cpr was stopped and the patient regained consciousness and return of spontaneous circulation was achieved.There was no neurological defect noted.The vad was exchanged.No further patient complications have been reported as a result of this event.
|
| |
|
Manufacturer Narrative
|
|
Investigation of this event is pending and a supplemental report will be sent upon its completion.This information was received from the mechanical circulatory support product surveillance registry study.Additional products: brand name: heartware ventricular assist system ¿controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 28-feb-2020 / serial#: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun.Device mfg date: 06-feb-2020, labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 28-feb-2020 / serial#: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, device mfg date: 06-feb-2020, labeled for single use: no.(b)(4).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 event details.The event description and the annex f codes have been up dated.> additional products: d4: serial #: (b)(6) h6: imf code(s): f19, f23 d4: serial #: (b)(6) h6: imf code(s): f19, f23 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.
|
| |
|
Event Description
|
|
It was further reported that the patient had received a femoral cannulation and intercoastal cryoablation.
|
| |
|
Manufacturer Narrative
|
|
###a supplemental is being submitted for additional information.Additional information: - b5 desc evt problem: updated to include more information regarding the symptoms, diagnosis, and intervention surrounding the event as well as to include thrombus allegation.- h6: updated to include ime code e0514 and imf code f0801 - h10: updated to include ime code e0514 and imf code f0801 for the two controllers as well as to include the outflow graft details and its' corresponding codes additional products: serial #: (b)(6) h6: ime code(s): e0514 h6: imf code(s): f0801 serial #: (b)(6) h6: ime code(s): e0514 h6: imf code(s): f0801 d1: heartware ventricular assist system ¿ outflow graft d4: model #: 1125 / catalog #: 1125 / expiration date: unk / lot#: 17409361-1276 udi #: asku d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: unk h5: yes h6: patient ime code(s): e00119, e0514 h6: imf code(s): f1903, f23, f1203, f08, f2303, f0801, f2306, f19 h6: img code(s): g04019 h6: fda device code(s): a1409 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 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.
|
| |
|
Event Description
|
|
It was further reported that the patient had initially called the clinic due to controller fault alarms and was asymptotic with the ¿vad numbers stable¿.The patient was instructed to go to the clinic for a controller exchange however, upon arrival, the patient reported fatigue and shortness of breath.The patient was then admitted for further workup and controller exchange.The controller was exchanged at bedside and the vad did not restart and the patient subsequently became unresponsive.Cpr was started while the controller was switched back to the original unit.The patient was later transferred to the intensive care unit (icu) after they regained consciousness and return of spontaneous circulation (rosc) was achieved.The patient was treated with ¿de-novo¿ for inotrope therapy and the vad was exchanged for a competitor brand as it was stated that device thrombus was confirmed and that there was thrombus o bstructing the outflow graft (ofg).
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for additional event details.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 is being submitted for additional information.Additional products: serial #: (b)(6) - controller 2.0 h6: fdm code(s): b15, b17 h6: fdr code(s): c02, c19 h6: fdc code(s): d15, d10 serial #: (b)(6)- controller 2.0 h6: fdm code(s): b17 h6: fdr code(s): c20 h6: fdc code(s): d14 lot#: 17409361-1276¿ outflow graft h6: fdm code(s): b17 h6: fdr code(s): c20 h6: fdc code(s): d12 product event summary: ventricular assist device (vad) (b)(6), the associated outflow graft (lot 17409361-1276), and two (2) controllers ((b)(6)) were not returned for evaluation.Log file analysis revealed that (b)(6) was the primary controller, initially in use during the reported event date.Log files associated with (b)(6) revealed that pump parameters were within normal operation range within the last 14 days of available data leading up to 07-sep-2022.Review of the alarm log file associated with (b)(6) revealed two (2) controller fault alarms, one (1) vad disconnect alarm, and one (1) vad stopped alarm were logged on 07-sep-2022.The controller fault alarms logged at 01:29:56 and 11:49:41, respectively, indicating an issue with the internal battery.Log files also revealed that the controller was in use for less than two (2) years.The vad disconnect alarm was logged at 11:58:56, likely due to troubleshooting during the reported controller exchange.A controller power up was then logged on 07-sep-2022 at 11:59:58, likely due to the reported ¿exchanged back to the original controller¿.The vad stopped alarm was then logged at 12:00:16 due to a failure of the pump to restart after several attempts.This was followed by a successful pump start event recorded on 07-sep-2022 at 12:00:49.As a result, the reported controller fault alarms, controller power up, and failure to restart events involving (b)(6) were confirmed.Controller log files pertaining to (b)(6) were not available for analysis.As a result, the reported failure to restart involving (b)(6) event could not be confirmed.Information provided by the site indicated that upon arrival to the clinic, the patient reported fatigue and shortness of breath.The patient was then admitted for further workup and controller exchange.The controller was exchanged at bedside and the vad did not restart and the patient subsequently became unresponsive and lost consciousness.Cardiopulmonary resuscitation (cpr) was started while the controller was switched back to the original unit.Medication was initiated and the vad ramped up in speed and eventually restarted.Noise from the vad could be heard from the patient's chest.Cpr was stopped and the patient was later transferred to the intensive care unit (icu) after they regained consciousness and return of spontaneous circulation (rosc) was achieved.It was further reported that the patient had received a femoral cannulation and intercoastal cryoablation.There was no neurological defect noted.The patient was treated with ¿de-novo¿ for inotrope therapy and the vad was exchanged for a competitor brand as it was stated that device thrombus was confirmed and that there was thrombus obstructing the outflow graft (ofg).The reported thrombus and pump noise events could not be confirmed due to insufficient evidence.Based on the available information, the device may have caused or contributed to the reported event.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; possible root causes of the reported controller fault alarms may be attributed, but not limited, to a faulty internal battery and/or a faulty internal battery charger integrated circuit.Based on the available information, the most likely root cause of the reported controller power up event can be attributed to the reported controller exchange back to the original controller.The most likely root cause of the vad stopped alarm can be attributed to failure of the pump to restart after several attempts.(b)(6) was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.Based on the risk documentation, the reported pump ¿noise from the vad¿ event 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 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 a history of respiratory dysfunction.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 is 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 corrections.D6a implanted date and 6b explanted date were inadvertently omitted.G2 report source was inadvertently omitted.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 as additional information has being received for this event.Updated section: b5 desc evt problem investigation of this event was completed and the file was 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 a small amount of aortic root clot was seen on the transesophageal echocardiography (tee) by the anesthesia.Also, dense adhesions throughout and loops on the driveline were found with the outflow graft.
|
| |
|
Search Alerts/Recalls
|
|
|
