HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1103 |
Device Problems
Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Power Problem (3010); Material Split, Cut or Torn (4008)
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Patient Problems
Cardiac Arrest (1762); Stroke/CVA (1770); Loss of consciousness (2418)
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Event Date 03/29/2022 |
Event Type
Injury
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Event Description
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It was reported that patient's family heard multiple alarms and found the patient unresponsive.The patient no longer had spontaneous respirations, after given cardiopulmonary resuscitation (cpr), advanced cardiovascular life support (acls) medications and defibrillated, respirations returned.Emergency medical service (ems) performed a controller exchange, placed two new batteries and the patient was taken to the hospital.The patient was intubated and is currently on ventilator support, unresponsive to outside stimuli, a computed tomography (ct) scan confirmed the patient had a cardiovascular accident (cva) evolving in the frontal lobes.It was noted that the controller exhibited a controller fault alarm and an unexpected power loss which resulted in a ventricular assist device (vad) stop.The vad remains in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Concomitant medical products: lead: 6935m62 implant date: (b)(6) 2013, lead: 407652 implant date: (b)(6) 2013, lead:439688 implant date: (b)(6) 2013 additional product: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420/ catalog #: 1420/ expiration date: 31-jan-2022 / serial#: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by mfr: no, device evaluation anticipated, but not yet begun, mfg date: 12-jan-2021, labeled for single use: no, (b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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### a supplemental report is being submitted for additional information and corrections.B5 was corrected to indicate that the controller exhibited a controller failed alarm, there was not a controller fault alarm, and log file review indicated that following the unexpected loss of power and the vad stop, the vad would not restart when power was restored.H6 was corrected to include the ime code e0602.In h10, the serial number for the system reported controller was corrected from (b)(6) to (b)(6) and the ime code e0602 was added.Newly received information in b5 indicated that the patient's waist pack was cut off by ems during the event and it was no longer usable.H10 was also updated with additional information for the system reported waist pack.Additional products: d4: serial or lot#: (b)(6) d9: yes, return date: 14-apr-2022 h3: dev rtn to mfr? yes h6: patient ime code(s): e0602 d1: heartware ventricular assist system ¿ waist pack d4: model #: 2050 / catalog #: 2050 / expiration date: 30-sep-2022 / serial or lot#: (b)(6) udi #: (b)(4) d9: no h4: mfg date: 21-sep-2021 h5: no h6: patient ime code(s): e0602, e0133, e0119 h6: imf code(s): f1203, f2306, f08, f2203 h6: img code(s): g04021 h6: fda device code(s): a0414 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.
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Event Description
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It was further reported that when the patient was found unresponsive the controller was no longer working, and the controller exhibited a controller failed alarm.There was not a controller fault alarm.Log file review indicated that following the unexpected loss of power and the vad stop, the vad would not restart when power was restored.During the event, the patient's waist pack was cut off by ems and it was no longer usable.
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Manufacturer Narrative
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###a supplemental report is being submitted for device evaluation.Additional products: serial# (b)(6) d9:yes (b)(6) 2022 h3:yes h6:fda method code(s): b01, b15 h6:fda result code(s): c19 h6:fda conclusion code(s): d10, d15 lot# 1783538 h6:fda method code(s): b17 h6:fda result code(s):c20 h6:fda conclusion code(s): d14 product event summary: the ventricular assist device (vad) ((b)(6)) and one (1) waist pack (lot no.1783538) were not returned for evaluation.One (1) controller ((b)(6)) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Failure analysis of the returned controller revealed that the device passed visual inspection and functional testing.Review of the controller log files associated with (b)(6) revealed this event was initiated by a controller power up event logged on 29/mar/2022 at 10:20:01.The data point prior to the loss of power revealed that a (b)(6) was connected to power port one (1) with 46% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 25% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port (1) and (b)(6) was connected to power port two (2).No anomalies were observed leading up to the loss of power.The controller was without power for twelve (12) seconds.Analysis of the alarm log file associated with (b)(6) revealed a vad stopped alarm was then logged on 29/mar/2022 at 10:20:29, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by several vad disconnect alarms due to a physical disconnection of the driveline from the controller and additional controller power up events, logged on 29/mar/2022, likely due to the reported troubleshooting and/or the reported controller exchange.Review of the alarm log file did not reveal any controller failed alarms recorded within the analyzed period.Log file analysis associated with (b)(6) revealed a controller power up event logged on 29/mar/2022 at 22:37:38 with a subsequent vad disconnect alarm logged at 22:37:43, likely indicating that the driveline was not connected to the controller.Review of the data log file associated with (b)(6) revealed that the controller was not in use prior to the controller power up event; the first data point was logged at 22:38:11 on 29/mar/2022, indicating that the power up event and vad disconnect alarm occurred during a controller exchange.A successful pump start event was then recorded at 22:37:58.As a result, the reported loss of power and vad stop associated with a failure to restart events were confirmed.The reported controller failed alarm event or damaged waist pack events could not be confirmed.Information received from the site indicated that, following the vad stop event, the patient unresponsive was found unresponsive and no longer had spontaneous respirations.After given cardiopulmonary resuscitation (cpr), advanced cardiovascular life support (acls) medications and being defibrillated, respirations returned.The patient was intubated and is currently on ventilator support, unresponsive to outside stimuli, a computed tomography (ct) scan confirmed the patient had a cardiovascular accident (cva) evolving in the frontal lobes.Per the instructions for use, neurological dysfunction and cardiopulmonary arrest are known potential complications associated with the implantation of a vad.There is no evidence the patient had a history of similar events.A possible root cause of the loss of power event can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa (b)(4) is investigating controller losses of power.Applicable risk documentation, experience with events of similar circumstances and the available information were considered; a possible root cause of the damaged waist pack event can be attributed to the handling of the device after the patient was found, as described in the event details.The most likely root cause of the vad stopped alarms 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 (b)(4)is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.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.
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Manufacturer Narrative
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A supplemental correction is being submitted for inclusion of this event as being in-scope for recall with z-0946-2021.This event was submitted historically and has been deemed in-scope for the field corrective action.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.
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