|
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; VENTRICULAR (ASSISST) BYPASS
|
Back to Search Results |
|
| Model Number 1103 |
| Device Problems
Obstruction of Flow (2423); Contamination /Decontamination Problem (2895); Material Integrity Problem (2978); Pumping Problem (3016)
|
| Patient Problems
Dizziness (2194); Discomfort (2330)
|
| Event Date 10/10/2021 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding the intervention 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.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
It was reported that the ventricular assist device (vad) exhibited low flow alarms and several consecutive high watt alarms which was not associated with change in position.It was noted that the patient felt "not herself" after the events and came to the emergency department (ed).It was further reported that there were concerns that the high power alarms could be from an issue with the driveline as the left ventricle (lv) did not appear to clot and that ingestion was possible.The patient anticoagulation was within goal and the vad was exchanged to a competitor device.No further patient complications have been reported as a result of this event.
|
| |
|
Manufacturer Narrative
|
|
Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding the intervention 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.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
It was reported that the ventricular assist device (vad) exhibited low flow alarms and several consecutive high watt alarms which was not associated with change in position.It was noted that the patient felt "not herself" after the events and came to the emergency department (ed).It was further reported that there were concerns that the high power alarms could be from an issue with the driveline as the left ventricle (lv) did not appear to clot and that ingestion was possible.The patient anticoagulation was within goal and the vad was exchanged to a competitor device.No further patient complications have been reported as a result of this event.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) 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.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 functional testing.Visual examination revealed scoring marks on the lower housing ceramic surface and on the inferior surface of the impeller.These friction marks are indicative that an external factor may have forced the impeller against the rear housing with sufficient strength to overcome the rear preload of the magnetic spring/suspension system, thus leading to scoring marks observed during visual inspection.Visual inspection also revealed metal material consistent with a stent within the outflow graft.Dimensional verification revealed that the back preload measurement, spring rate, rear housing disc curvature, and front housing disc curvature were found to be deviating from release specifications.Internal pathology report revealed no evidence of thrombus within the pump.Log file analysis revealed a spike in power consumption on (b)(6) 2021 and six high watt alarms logged on (b)(6) 2021.Additionally, one high watt alarm was logged on (b)(6) 2021 and seven low flow alarms were logged since (b)(6) 2021.As a result, the reported high power and low flow events were confirmed.Based on the available information, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.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, and/or inappropriate pump rotational speed.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, thrombus is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had previously experienced a potential thrombus event.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.
|
| |
|
Event Description
|
|
It was further reported that the ventricular assist device (vad) had unexplained power spikes.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for additional event details.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.
|
| |
|
Event Description
|
|
It was further reported that the patient heard alarms while ¿cooking and running around the house,¿ ¿while laughing hard and then later when moving around and doing things in (their) living room.¿ the patient was asymptomatic with an ¿associated sensation of vibration in the chest¿ and were sitting still in bed during the power increase.The low flow alarms ¿appeared to increase with time¿ and were transient.They also reported feeling lightheaded, but were unsure if this was due to ¿feeling anxious about the vad.¿ the patient presented to the emergency department where their ldh was 438 and a computed tomography angiography (cta) showed appropriate/unchanged vad position.The patient was due to be discharged, but another alarm prompted admission.The patient was given intravenous (iv) fluids for low flows and started on blood thinners.It was also reported that there was no obvious embolic event after the power spikes.An echocardiogram was performed without evidence of thrombus and a computed tomography angiography (cta) showed appropria te/unchanged vad position.It was also reported that the vad driveline outer sheath had ultraviolet (uv) damage and general wear from torqueing and being coiled frequently.During the vad exchange, an ¿obstruction-like event with flow to 0.6 lpm and hi w to 10 followed by two more hi w alarms to 5.6 and 7.4 before support terminated.¿ transesophageal echocardiogram (tee) was performed without evidence of thrombus.No thrombus seen in inflow cannula or outflow graft, nor in left ventricle.There was a ¿typical ring thrombus around base of inflow cannula, non-obstructive and densely adherent.¿.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for additional event details.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.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted to correct the event 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.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for device evaluation and an update to the investigation summary.Revised product event summary: the ventricular assist device (vad) 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.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 functional testing.Visual examination revealed scoring marks on the lower housing ceramic surface and on the inferior surface of the impeller.These friction marks are indicative that an external factor may have forced the impeller against the rear housing with sufficient strength to overcome the rear preload of the magnetic spring/suspension system, thus leading to scoring marks observed during visual inspection.Visual inspection also revealed metal material consistent with a stent within the outflow graft.Dimensional verification revealed that the back preload measurement, spring rate, rear housing disc curvature, and front housing disc curvature were found to be deviating from release specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Internal pathology report revealed no evidence of thrombus within the pump.Log file analysis revealed a spike in power consumption on 30-nov-2021 and six (6) high watt alarms logged on 30-nov-2021.Eight (8) additional high watt alarms had been logged between 30-sep-2021 and 15-nov-2021 and twelve (12) low flow alarms were logged since 29-sep-2021.As a result, the reported high power and low flow events were confirmed.The reported driveline damage, vibration, and obstruction events could not be confirmed due to insufficient evidence.Hw21999 is in scope of fa1243, which was initiated for pumps with a potential manufacturing issue that may result in demagnetization of the center-post.While hw21999 is in scope of fa1243, visual inspection at high magnification of the cap weld, impeller inner diameter, and center post did not reveal any indication of an issue that may have caused or contributed to a premature demagnetization of the center-post.Based on the available information, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.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, and/or inappropriate pump rotational speed.Based on the risk documentation and the available information, the most likely root cause of the reported "vibration" event may be attributed to multiple factors including but not limited to thrombus within the device leading to impeller imbalance or the placement of the pump which allows contact with fixed or rigid anatomical structure.Based on historical review of similar events, possible root causes of the reported driveline damage event may be attributed to multiple factors including but not limited to design issues, exposure to uv light, wear, and/or handling.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, thrombus is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had previously experienced a potential thrombus event.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.
|
| |
|
Search Alerts/Recalls
|
|
|
