HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE; VENTRICULAR (ASSISST) BYPASS
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Model Number 1103 |
Device Problems
Material Discolored (1170); Difficult to Remove (1528); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2022 |
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: brand name: heartware ventricular assist system ¿ driveline cover model #: 1175, catalog #: 1175, expiration date: unk / lot#: unk udi #: asku device available for evaluation: no.Mfg date: unk no patient ime code(s): e2403 imf code(s): f26 ,img code(s): g04037 , fda device code(s): a150207, fda method code(s): b21, fda results code(s): c21.Additional information has been requested regarding the servicing, driveline cover lot number, and log files, 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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Event Description
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It was reported that while the patient was in the clinic, the ventricular assist device (vad) coordinator tried to pull back the dri veline cover but was not able to remove it.While the vad coordinator was out of the room, the patient manipulated the driveline cover and stripped the driveline connector nut.It was determined that a driveline splice repair would need to be performed.A servicing was planned to be performed.The driveline and driveline cover remain in use.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 patient was admitted for repair servicing and was given a heparin bolus.A driveline splice repair was performed.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Newly received information indicates that the patient was admitted and underwent a driveline splice repair.New information also provided the patient weight.Additional products: unknown driveline boot cover h6: imf code(s): f08, f12, f2304 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 inclusion of this event as being in-scope for field action 3007042319-12-06-2022-005-c.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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Manufacturer Narrative
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A supplemental report is being submitted for a correction and update to: corrected b5.Desc evt problem.Updated: h6.Device codes (fdd/annex a) updated: h10 additional product, added lot# additional product: d1: driveline cover d4: lot#: r015860 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 the driveline outer sheath looked brown.
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Manufacturer Narrative
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A supplemental report is being submitted for analysis and investigation completion.Additional products: driveline cover d9: yes return date: 2022-08-31 h3:yes h6:fda method code(s): b01, b14 h6:fda result code(s): c06, c07 h6:fda conclusion code(s): d1501 product event summary: a segment of the driveline cable associated with (b)(6) and the driveline boot cover (lot no.R015860) were returned for evaluation.A review of the driveline cover's inspection documentation and the pump's manufacturing documentation confirmed that the associated devices met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Log file analysis revealed that (b)(6) was the patient's primary controller, in use during the reported event.Log file analysis associated with (b)(6) revealed an electrical fault alarm logged on (b)(6) 2022 at 12:23:10 and several reactivation events logged on (b)(6) 2022 between 12:23:05 and 12:23:14 due to an open phase on the rear stator, resulting in single stator operation (front stator only).Log file analysis pertaining to (b)(6) revealed two (2) controller power-up events logged on (b)(6) 2022 at 13:23:25 and 13:55:45 with associated pump start event logged at 13:55:45, indicating that the controller was put into use following a controller exchange during the reported splice repair.Analysis of the alarm log file associated with (b)(6) revealed one (1) electrical fault alarm, one (1) high watt alarm, and one (1) vad disconnect alarm logged on (b)(6) 2022.The electrical fault alarm was logged at 13:56:59 due to an open phase on the front stator, resulting in single stator operation (rear stator only).This likely triggered the subsequent high watt alarm, due to the increased power consumption required to run on a single stator.Review of the event log file associated with (b)(6) revealed several reactivation events logged on (b)(6) 2022 between 13:56:55 and 13:57:03 due to an open phase on the front stator, resulting in single stator operation.A vad disconnect alarm was logged at 14:03:47 indication a physical disconnection of the driveline from the controller, likely due to troubleshooting of the alarms.The driveline was reconnected, followed by a subsequent pump start event at 14:03:59.These are additional findings not related to the reported event.Based on risk documentation and the available information, a possible root cause of the observed electrical fault alarms, high watt alarm, and reactivation events can be attributed, but not limited, to contamination by foreign material of the driveline connector and/or a marginal driveline connection during the reported splice repair.The most likely root cause of the observed vad disconnect alarm can be attributed to a physical disconnections of the driveline from the controller, during the reported splice repair due to troubleshooting of the observed electrical fault alarms.Visual examination of the returned driveline boot cover, as well as on-site inspection of the driveline boot cover and visual evidence provided by the site, revealed that the driveline connector body back nut was stuck inside the returned driveline boot cover and hardening of the boot cover.Therefore, functional testing of the driveline boot cover could not be performed.Additionally, visual inspection revealed slight discoloration around the edges of the device.Dimensional verification revealed that the driveline cover¿s inner diameters were found to be below specification.Supplemental testing performed on similar samples revealed that, compared to a control sample, the driveline covers analyzed had a decrease in plasticizer content and lower absorbance ratio, indicating that the plasticizer may have degraded.Further testing also revealed a greater mass loss, glass transition temperature, and young¿s modulus than the control sample, resulting in a much stiffer material.Visual examination of the returned segment of the driveline cable, as well as on-site inspection of the driveline and visual evidence provided by the site, revealed that, in addition to the connector damage, the driveline strain relief was missing indicating that the strain relief had been damaged and discoloration of the outer sheath.Additionally, a kink and a crack in the outer sheath were observed.Functional testing of the driveline segment revealed that the driveline passed the continuity test and locking mechanism test.As a result, the reported difficulty removing the driveline cover, driveline sheath discoloration, and connector damage events were confirmed.The observed driveline sheath kink damage is an additional finding not related to the reported event.A driveline splice procedure was performed to mitigate the reported conditions.The most likely root cause of the observed driveline sheath kink damage may be attributed to multiple factors, including but not limited to wear and/or handling of the driveline.Based on historical review of similar events and the investigation conducted, a possible root cause of the reported difficulty removing the driveline cover event can be attributed, but not limited, to leaching of the plasticizer from the material and/or degradation of the material, resulting in hardening and shrinkage.Capa pr00536773 is further investigating this issue.Based on historical review of similar events, the most likely root cause of the observed driveline sheath crack damage and discoloration may be attributed to multiple factors including design issues and/or exposure to uv light.The most likely root cause of the driveline connector damage and missing strain relief can be attributed to the reported improper handing of the device by the patient, including the manipulation of the device while trying to remove the stuck driveline cover.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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