|
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSIST) BYPASS
|
Back to Search Results |
|
| Model Number 1103 |
| Device Problems
Electrical /Electronic Property Problem (1198); Failure to Pump (1502); Pumping Stopped (1503)
|
| Patient Problems
Heart Failure (2206); Heart Failure/Congestive Heart Failure (4446)
|
| Event Date 09/16/2019 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
It was reported that the patient heard a medium priority alarm that progressed to a high priority electrical fault alarm.They exchanged the controller for troubleshooting, but the alarm did not resolve.The high priority alarm continued, and the alarm message read "ventricular assist device (vad) stopped change controller" and all the values displayed were at zero.The drive line was disconnected from the controller and the vad was turned off as instructed; however, was unable to restart.The patient was transferred to the hospital and was administered anticoagulants and inotropes.The patient experienced worsening heart failure.The patient¿s drive line was inspected and there was no obvious wire damage.The vad was exchanged.No further patient complications have been reported as a result of this event.
|
| |
|
Manufacturer Narrative
|
|
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 is a participant in the destination therapy trial improved blood pressure management clinical study.
|
| |
|
Manufacturer Narrative
|
|
Product event summary: the vad with a segment of the associated driveline cable, and the controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.Review of the vad's manufacturing documentation confirmed that the associated device met all requirements for release.Review of the controller log files revealed five electrical fault alarms starting at 16:36:09, indicating an overcurrent condition resulting in the pump running on a single stator (rear-stator only).A vad stopped alarm was logged at 16:37:11 due to a failure of the pump to restart after several attempts.This was followed by several more electrical fault, vad stopped, and vad disconnect alarms.As a result, the reported event was confirmed.Failure analysis of the returned controllers revealed that the devices passed visual inspection and functional examination.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the device.Functional testing of the driveline segment revealed that the driveline passed the continuity and locking mechanism test.Visual examination of the driveline connector did not reveal any damage to the connector, recessed pins, and/or foreign material inside the connector that may have compromised the mechanical/electrical performance of the returned device.Visual inspection revealed yellowing and breaks of the outer sheath of the driveline; however no damaged wires were observed.Since the entire length of the driveline cable was not returned for evaluation, it is possible that the wires were damaged in a segment which was not received or at the site where the driveline was cut.An internal investigation revealed driveline sheath damages.Based on the investigation conducted, the most likely root cause of driveline sheath damage may be attributed to multiple factors including design issues and/or exposure to uv light.The most likely root cause of the reported electrical fault alarms can be attributed to a short circuit within the driveline cable, likely due to wire damage.An internal investigation evaluated failures of the pump to restart at the system level (interaction between the pump and peripheral device).Based on an extensive investigation conducted, the likely contributing causes for failure to restart come from the presence of increased starting resistance in a very small number of implanted patients.This resistance is likely specific to the physiology of these patients, an area of limited access for further investigation.Therefore, no actionable root causes were identified.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 12-sep-2018 / serial #: (b)(4) udi #:(b)(4) d10: yes, return date: (b)(6)2019 h3: yes dev rtn to mfr? yes h4: mfg date: 12-sep-2017 h5: no h6: patient code(s): c76143 h6: device code(s): c63007 h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 4310 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 controller was returned to the manufacturer due to an associated device and subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for a correction.Correction: b5 description of event: added information about the status of the controllers.H6: added codes.H10: added (b)(6) as an additional reported device and included the associated product event summary, (b)(6) h6 codes added.Product event summary: log file analysis revealed that (b)(6) was originally in use at the time of the reported event.Review of the controller log files associated with (b)(6) revealed an electrical fault alarm logged on (b)(6) 2019 at 16:16:26 indicating an overcurrent condition resulting in the pump running on a single stator (rear-stator only).This likely triggered the subsequent high watt alarm, logged at 16:16:28, due to the increased power consumption required to run on a single stator.Two (2) vad disconnect alarms were then logged at 16:19:31 and 16:30:08, indicating physical disconnections of the driveline from the controller, likely during troubleshooting and the reported controller exchange.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-oct-2018 / serial #: (b)(6) udi #: (b)(4) d9: yes, return date: 2019-09-24 h3: yes dev rtn to mfr? yes h4: mfg date: 31-oct-2017 h5: no h6: patient ime code(s): e0611 h6: imf code(s): f1203, f08, f2303 h6: img code(s): g04035 h6: fda device code(s): a141204, a07 h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d1: heartware ventricular assist system ¿ controller 2.0 serial #: (b)(6) h6: patient ime code(s): e0611 h6: imf code(s): f1203, f08, f2303 h6: img code(s): g04035 h6: fda device code(s): a141204 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 primary and back up controllers were removed from service.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for a correction.Correction: g3 date received by manufacturer, was changed from "blank" on regulatory report # 3007042319-2019-11983 to 19-jul-2021 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 h6.Fdr, fdc codes and h10.Product event summary.Product event summary: the ventricular assist device (vad) ((b)(6)), with a segment of the associated driveline cable, and two (2) controllers (con313748, con312321) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.Review of (b)(6) manufacturing documentation confirmed that the associated device met all requirements for release.Log file analysis revealed that con313748 was originally in use at the time of the reported event.Review of the controller log files associated with con313748 revealed an electrical fault alarm logged on (b)(6) 2019 at 16:16:26 indicating an overcurrent condition resulting in the pump running on a single stator (rear-stator only).This likely triggered the subsequent high watt alarm, logged at 16:16:28, due to the increased power consumption required to run on a single stator.Two (2) vad disconnect alarms were then logged at 16:19:31 and 16:30:08, indicating physical disconnections of the driveline from the controller, likely during troubleshooting and the reported controller exchange.Review of the controller log files associated with con312321 revealed five (5) electrical fault alarms starting at 16:36:09, indicating an overcurrent condition resulting in the pump running on a single stator (rear-stator only).A vad stopped alarm was logged at 16:37:11 due to a failure of the pump to restart after several attempts.This was followed by several more electrical fault, vad stopped, and vad disconnect alarms.As a result, the reported event was confirmed.Failure analysis of the returned controllers revealed that the devices passed visual inspection and functional examination.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the device.Functional testing of the driveline segment revealed that the driveline passed the continuity and locking mechanism test.Visual examination of the driveline connector did not reveal any damage to the connector, recessed pins, and/or foreign material inside the connector that may have compromised the mechanical/electrical performance of the returned device.Visual inspection revealed yellowing and breaks of the outer sheath of the driveline; however, no damaged wires were observed.Since the entire length of the driveline cable was not returned for evaluation, it is possible that the wires were damaged in a segment which was not received or at the site where the driveline was cut.Capa00188 investigated driveline sheath damages.Based on the investigation conducted under capa00188, the most likely root cause of driveline sheath damage may be attributed to multiple factors including design issues and/or exposure to uv light.Even though this capa is closed, (b)(6) falls within the bounds of this capa.The most likely root cause of the reported electrical fault alarms can be attributed to a short circuit within the driveline cable, likely due to wire damage.The most likely root cause of the vad stopped alarms can be attributed to failures of the pump to restart after several attempts.(b)(6) is 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.An internal 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.
|
| |
|
Search Alerts/Recalls
|
|
|
