Model Number 106524US |
Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Thromboembolism (2654); Convulsion/Seizure (4406); Hemorrhagic Stroke (4417)
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Event Date 06/06/2022 |
Event Type
Death
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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It was reported that the patient died of an arterial non-cerebral venous sinus thromboembolism.The treatment performed prior was surgery and changes to medication.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not conclusively be established through this evaluation.The pump will not be returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 08mar2022.The heartmate 3 left ventricular assist system (lvas) instruction for use (ifu) (rev.G) is currently available.Section 1 of this document lists bleeding, arterial non-central nervous system (cns) thromboembolism, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 entitled ¿patient care and management¿ also lists thromboembolism as a potential late postimplant complication.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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It was reported that the patient was hospitalized and emergency operation was performed, but the bleeding area was too broad.There were no changes to pump parameters or the patient's anticoagulation status or condition that may have contributed.
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Manufacturer Narrative
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No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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It was reported that the patient visited emergency and a massive intracranial hemorrhage was found that required surgical intervention and changes to medication.The patient had a history of stroke with intracranial hemorrhage a year prior.After craniotomy, the brain lesion remained stable so the left ventricular assist device was performed.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not conclusively be established through this evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate 3 lvas instruction for use (ifu), is currently available.Section 1 of this document lists stroke, neurologic dysfunction, bleeding, arterial non-central nervous system (cns) thromboembolism, pump thrombosis, infection, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 entitled ¿patient care and management¿ also lists thromboembolism and neurological dysfunction as a potential late postimplant complication.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.The care instructions in regard to preventing infection are provided in various sections of the ifu, including controlling infection.The heartmate 3 lvas patient handbook, is also currently available and contains information about preventing infection.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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On (b)(6) 2022, the patient visited the emergency for a seizure.A massive intracranial hemorrhage was found in an image, and patient underwent an emergency operation, but the bleeding area was too broad.Arterial non-central nervous system (cns) thromboembolism and suspected device thrombosis were also reported.The patient ultimately expired on (b)(6) 2022.The account stated that the death was caused by hemorrhagic stroke in neurologic dysfunction.The account later communicated that there were no changes to the patient¿s condition or anticoagulation status that may have contributed to the event.No changes were made to the device and no computed tomography (ct) imaging was available.The account communicated that the device was operating without any problem at the time.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not conclusively be established through this evaluation.It was communicated that the patient had a history of stroke with intracranial hemorrhage.After craniotomy, the patient¿s brain lesion remained stable, so a left ventricular assist device (lvad) implant was performed.On (b)(6) 2022, the patient visited the emergency for a seizure.A massive intracranial hemorrhage was found in an image, and patient underwent an emergency operation, but the bleeding area was too broad.Arterial non-central nervous system (cns) thromboembolism and suspected device thrombosis were also reported.The patient ultimately expired on (b)(6) 2022.The account stated that the death was caused by hemorrhagic stroke in neurologic dysfunction.The account later communicated that there were no changes to the patient¿s condition or anticoagulation status that may have contributed to the event.No changes were made to the device and no computed tomography (ct) imaging was available.The account communicated that the device was operating without any problem at the time.Lastly, the account stated that the pump will not be returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate 3 left ventricular assist system (lvas) instruction for use (ifu) is currently available.Section 1 of this document lists stroke, neurologic dysfunction, bleeding, arterial non-central nervous system (cns) thromboembolism, pump thrombosis, infection, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 entitled ¿patient care and management¿ also lists thromboembolism and neurological dysfunction as a potential late postimplant complication.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.The care instructions in regard to preventing infection are provided in various sections of the ifu, including controlling infection.The heartmate 3 lvas patient handbook, is also currently available and contains information about preventing infection.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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Additional information reported that the patient passed away on (b)(6) 2022.
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Event Description
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Additional information reported that the event started on 06jun2022, and the patient passed away on (b)(6) 2022.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event could not conclusively be established through this evaluation.It was communicated that the patient had a history of stroke with intracranial hemorrhage.After craniotomy, the patient¿s brain lesion remained stable, so a left ventricular assist device (lvad) implant was performed.On (b)(6) 2022, the patient experienced neurological dysfunction and hemolysis.On (b)(6) 2022, the patient visited the emergency for a seizure.A massive intracranial hemorrhage was found in an image, and patient underwent an emergency operation, but the bleeding area was too broad.Arterial non-central nervous system (cns) thromboembolism and suspected device thrombosis were also reported.In addition, the patient was found positive for covid-19.The patient ultimately expired on (b)(6) 2022.The account stated that the death was caused by hemorrhagic stroke in neurologic dysfunction.The account later communicated that there were no changes to the patient¿s condition or anticoagulation status that may have contributed to the event.No changes were made to the device and no computed tomography (ct) imaging was available.The account communicated that the device was operating without any problem at the time.Lastly, the account stated that the pump will not be returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate 3 lvas instruction for use (ifu) is currently available.Section 1 of this document lists stroke, neurologic dysfunction, bleeding, arterial non-central nervous system (cns) thromboembolism, pump thrombosis, hemolysis, infection, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 entitled ¿patient care and management¿ also lists thromboembolism and neurological dysfunction as a potential late postimplant complication.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.The care instructions in regard to preventing infection are provided in various sections of the ifu, including controlling infection.The heartmate 3 lvas patient handbook, rev.G.Is also currently available and contains information about preventing infection.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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