HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; VENTRICULAR (ASSISST) BYPASS
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Model Number 1103 |
Device Problems
Obstruction of Flow (2423); Pumping Problem (3016)
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Patient Problems
Bacterial Infection (1735); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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Event Date 02/01/2022 |
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.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) exhibited elevated flows and powers.The patient went to sleep to see if it would get better.The next day, the patient was admitted.A review of log files revealed that approximately one week prior, the vad exhibited a sharp drop in flow and power.Three days later, the vad flow and power began climbing steadily associated with multiple high watt alarms.A thrombus in the vad was suspected.It was noted that the patient was also on their menstrual cycle or it was precipitated by anticoagulation.Review of the patient¿s recent international normalized ratio (inr) values revealed that the patient¿s international normalized ratio (inr) was subtherapeutic the week prior to the suspected thrombus.The patient was instructed to take one increased dose of warfarin and then resume the regular dose.Six weeks prior, the patient¿s inr was 1.71.The patient recalls missing one dose of warfarin prior to the inr at 1.71.It was also noted that the patient¿s driveline dressing was becoming saturated very frequently and the patient has been on intravenous (iv) daptomycin for approximately one month for methicillin-sensitive sta phylococcus aureus/methicillin-resistant staphylococcus aureus at the driveline exit site.The patient was also given a one time dose of oral fluconazole though they had not yet taken it.The vad and driveline remain in use.No further 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 to: b5.Desc evt problem b7.Relevant history additional products: d1: heartware ventricular assist system ¿outflow graft d4: model #: 1125 / catalog #: 1125 / expiration date: 31-jan-2022/lot#: 16135371-9778 udi #:(b)(4).D9: no h4: mfg date: unk h5: yes h6: patient ime code(s): e2328 h6: imf code(s): f1203, f008, f23 h6: img code(s): g04019 h6: fda device code(s): a1409 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 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 patient remains hospitalized and listed for transplant.Patient received at total of three (3) doses of tissue plasminogen activator (tpa) and underwent outflow graft stenting.The ventricular assist device (vad) also exhibited several instances of low flows after the tpa was administered.
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Manufacturer Narrative
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A supplemental report is being submitted as additional information has being received for this event.Updated section: b5 desc evt problem, h6 imf code.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 patient received 2 doses of tissue plasminogen activator (tpa) and remains in the hospital.
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Manufacturer Narrative
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### a supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) and the associated outflow graft were not returned for evaluation.The reported high power and low flow events were confirmed through review of log files and autologs, which revealed multiple increases in power consumption and estimated flows starting (b)(6) 2022, leading to the parameters above normal operating range, and a sudden decrease in power consumption and estimated flows on (b)(6) 2022 to the parameters below normal operating range.Seventy four (74) high watt alarms have been logged since (b)(6) 2022 and three (3) low flow alarms were logged on (b)(6) 2022 within analyzed period.Information received from the site revealed that the patient was suspected for thrombus and had menstrual cycle precipitated by anti-coagulation.The patient's international normalized ratio (inr) was subtherapeutic, a week prior to the suspected thrombus.The patient was instructed for one additional dose of warfarin.The patient recalled a missing dose of warfarin.The patient had its driveline dressing saturated frequently and was on intravenous (iv) daptomycin for a month due to infection at driveline exit site.Additionally, the patient also received a dose of oral fluconazole.Later, the patient received three (3) doses of tissue plasminogen activa tor (tpa) and underwent outflow graft stenting.Additionally, the patient revealed multiple instances of low flows after receiving tpa.Based on the available information, the device may have caused or contributed to the reported event.Based on historical review of similar high power events, 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 reported 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.Per the instructions for use, infection and device thrombus are known potential complications associated with the implantation of an vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of thrombus and infection events.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, including care of the driveline exit site.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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