HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1104 |
Device Problems
Obstruction of Flow (2423); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/25/2022 |
Event Type
Death
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Event Description
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It was reported that the patient died, suspected to be due to an outflow graft blockage.It was also noted via imaging, that the position of the ventricular assist device (vad) changed significantly from one day to the next, shifting downward.The vad team was unsure if this was normal or a bad clinical condition.An echocardiogram was performed which showed the patient had ventricular pacing, no respiratory variation and backflow to liver veins.The vad has been explanted.
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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: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 30-apr-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: 17-apr-2019, labeled for single use: no, (b)(4).Brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 28-feb-2022/ 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: 22-feb-2021, labeled for single use: no (b)(4).Brand name: heartware ventricular assist system ¿ outflow graft, model #: 1125 / catalog #: 1125 / expiration date: unk/ serial or lot#: unknown, udi #:(b)(4), device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, device mfg date: unk, labeled for single use: no, (b)(4).Additional information has been requested regarding the event details of the event, 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.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 analysis and investigation completion.Additional products: con406408 h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 con415835 h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 outflow graft -unknown h6: fda method code(s): b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 product event summary: the pump ((b)(6)), a segment of the associated outflow graft with unknown lot number, and two (2) controllers (con406408, con415835) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.A review of (b)(6) manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned controllers revealed that the devices passed visual inspection and functional testing.Log file analysis revealed that con415835 was the patient's primary controller.Review of the log files associated with con415835 revealed consistent power consumption below the normal operating range within the analyzed period.A decrease in power consumption and estimated flow was logged starting on 23/sep/2022.Four (4) low flow alarms were logged on 25/sep/2022 starting at 10:58:38, along with four (4) vad disconnect alarm logged starting at 12:15:23, indicating a physical disconnection of the driveline from the controller.Log file analysis associated with con406408 revealed that the controller was not in use during the reported event and was likely the patient's backup controller.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the front and rear housing disc curvatures were found to be devia ting from specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Failure analysis of the returned outflow graft segment revealed that the device passed visual examination.Internal pathological report revealed no evidence of thrombus within the devices.Information received from the site indicated that the patient died due to a suspected outflow graft blockage.It was also noted via imaging, that the position of the ventricular assist device (vad) changed significantly from one day to the next, shifting downward.An echocardiogram was performed which showed the patient had ventricular pacing, no respiratory variation and backflow to liver veins.The vad has been explanted.As a result, the reported malposition and outflow graft blockage events could not be confirmed due to insufficient evidence; however, the observed low flows are likely related to the reported event.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 low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling.Per the instructions for use, death is a known potential complication associated with the implantation of a vad.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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