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)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2021 |
Event Type
malfunction
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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 information has been requested regarding the date of device implant, 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.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 ventricular assist device (vad) had a delay in restarting after a proactive controller exchange.The vad remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Newley added d4: expiration date, d6a :the implant date, and h4 manufacture date.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.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.Describe event or problem corrected to include "it was further reported that the controller contributed to the vad stop and the delay in the vad restarting.The controller remains in use." additional manufacturer narrative was corrected to include an additional product.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420-controller/ catalog #: 1420-controller, expiration date: 31-jul-2020, serial #: (b)(6), udi #: (b)(4).D9: no.H3: no, device evaluation anticipated, but not yet begun.H4: mfg date: 31-jul-2019 h5: no h6: patient ime code(s): e2403.Imf code(s): f26.H6: fda device code(s): a141204.H6: fda results code(s): c21.H6: fda conclusion code(s): d16.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.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 controller contributed to the vad stop and the delay in the vad restarting.The controller remains in use.
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Event Description
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A second controller was returned to the manufacturer because it was proactively changed and it was estimated that the internal battery would soon be depleted.The controller subsequently tested out of specification during manufacturer¿s analysis.
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Manufacturer Narrative
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A supplemental report is being submitted for analysis and investigation completion.An additional device is being reported because it was returned to the manufacturer and subsequently tested out of specification during manufacturer¿s analysis.Product event summary: the ventricular assist device (vad) and one controller were not returned for evaluation.One controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned controller revealed that the controller passed functional testing.External visual inspection revealed contamination in power ports 1 and 2 as well as the serial data port.Visual inspection under 10x magnification revealed hairline cracks surrounding power port 2.An internal visual inspection did not reveal fluid ingress.The observed hairline cracks and power/serial port contamination are not related to the reported event.The most likely root cause of the contamination can be attributed to the handling of the device.Based on an investigation conducted under (b)(4), the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Review of the controller log files associated with the returned controller revealed a vad disconnect alarm on (b)(6) 2021 at 17:57:11 indicating a physical disconnection of the driveline from the controller, which correlates with the reported controller exchange.Review of the controller log files associated with the other controller revealed two controller power up events on (b)(6) 2021 at 17:36:06 and 18:20:42.A successful motor start was logged after two (2) attempts at 18:20:55, indicating normal pump behavior.Review of the data file associated with the other controller revealed that the first data point was recorded at 18:21:19, indicating that the device was not in use prior to the controller power up events and likely occurred during the reported controller exchange.The two (2) attempts recorded on the controller log files during the pump restart sequence was likely related to the reported "delay in restarting" event.Additionally, it is likely the controller exchange is related to the reported "controller contributed to the vad stop and the delay in the vad restarting".As a result, the reported event was confirmed.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the available inf ormation, a possible root cause of the reported vad stopped event may be attributed to the physical disconnect of the driveline from the controller during a controller exchange.Additional products: d4: serial #: (b)(6), h3: yes, h6: fda method code(s): b15, b17, h6: fda results code(s): c19, h6: fda conclusion code(s): d14; d1: heartware ventricular assist system ¿ controller 2.0, d4: model #: 1420, catalog #: 1420, expiration date: 31-dec-2018, serial#: (b)(6), udi #: (b)(4), d9: yes, return date: 01-apr-2021, h3: yes dev rtn to mfr? yes, h4: mfg date: 20-dec-2017, h5: no, h6: patient ime code(s): e2403, h6: imf code(s): f26, h6: fda device code(s): a12, h6: fda method code(s): b01, b15, h6: fda results code(s): c07, c15, h6: fda conclusion code(s): d01, 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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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.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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