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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1104 |
| Device Problems
Failure to Pump (1502); Pumping Stopped (1503); Use of Device Problem (1670)
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| Patient Problems
Diaphoresis (2452); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 12/08/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system ¿ controller, model #: 1420 / catalog #: 1420 / expiration date: unk/ serial #: unknown, udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: unk.Labeled for single use: no.(b)(4).Additional information has been requested regarding the vad explant, controller serial number, and other event details, but it was not available at the time of this 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 reported that the patient accidentally disconnected both power sources from the controller and the ventricular assist device (vad) stopped.After reconnecting the power sources, the vad did not restart.The controller was exchanged and the vad did not restart.The vad is planned to be exchanged.No patient complications have been reported as a result of this event.
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Event Description
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It was further reported that the controller remains in use and is functioning.
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Manufacturer Narrative
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This supplemental is being submitted for additional information that the controller remains in use.B5 event description was updated accordingly.D8 and d9 were also updated due to vad being returned for analysis.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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Manufacturer Narrative
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A supplemental report is being submitted for additional h10 reported controller, implant date d6, b6 event details h6 patient code.Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system ¿ controller d4: model #: 1420/ catalog #: 1420 / expiration date: 31-mar-2018/ serial #: (b)(6), udi #: (b)(4), d10 h4: mfg date: 31-mar-2017, h6: patient ime code(s): e2310 h6: imf code(s): f23.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 the patient was cold and sweaty during the vad stop and was given saline.
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Manufacturer Narrative
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A supplemental report is being submitted to revise adverse event or product to "adverse event <(>&<)> product problem." 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 report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) was returned for evaluation.The controller was not 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.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the rear housing disc curvature and front housing disc curvature were found to be deviating from specifications.Given that the pump met specifications prior to release, these deviations were likely a result of the clinical challenge to the pump, and, based on the null impact on the wet test power consumption, this deviation is not expected to impact pump performance.Internal pathological report revealed no evidence of thrombus within the device.Review of log files revealed a controller power up event on (b)(6) 2020 at 10:11:51.The data point prior to the loss of power revealed that a battery was connected to power port one (1) with 94% relative state of charge (rsoc) and another battery was connected to power port two (2) with 89% rsoc.The data point recorded after the loss of power revealed that a battery was connected to power port one (1) and another battery was connected to power port two (2).The controller was without power for 11 seconds.A vad stopped alarm followed at 10:12:18 indicating that the motor failed to restart on multiple attempts and was followed by several additional vad stopped alarms and controller power up events.Additional vad disconnect alarms were also recorded indicating a physical disconnection of the driveline from the controller, likely due to the reported controller exchange and/or troubleshooting of the alarms.As a result, the reported event was confirmed.The most likely root cause of the loss of power can be attributed to the reported disconnection of both power sources from the controller as described in the event details.The most likely root cause of the vad disconnect alarms can be attributed to a physical disconnection of the driveline from the controller.The most likely root cause of the vad stopped alarms can be attributed to a failure of the pu mp to restart after several attempts.The vad is part an internal investigation evaluating pump failures to restart.Additional products: d4: serial or lot#: (b)(6), h3: yes, h6: fda method code(s): b15, b17, h6: fda results code(s): c19, h6: fda conclusion code(s): d10, d11.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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Event Description
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It was further reported that the vad was exchanged.
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Manufacturer Narrative
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A supplemental report is being submitted as a new internal investigation has been assigned to this event.Also, updated section h6.Section h6 update for additional device: serial# (b)(6) h6: img code(s):g04035 the ventricular assist device (vad) hw29363 is not in scope of capa pr00502194.Capa pr00532915 was initiated to investigate pump failures to restart outside the subpopulation of capa pr00502194.Investigation is pending.A report will be sent when root cause for the internal investigation has been determined.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 report is being submitted for correction.Section h1 was corrected.This regulatory report is being submitted as part of a retrospective review and remediation due to an fda audit observation.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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