Model Number 50 CC OR 70 CC |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Cardiomyopathy (1764); Hemolysis (1886); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Renal Failure (2041); Respiratory Failure (2484); Patient Problem/Medical Problem (2688); Heart Failure/Congestive Heart Failure (4446); Renal Impairment (4499); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Death
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Manufacturer Narrative
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The syncardia 70cc temporary total artificial heart (tah-t) is an implantable pulsatile biventricular replacement device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation systems.The syncardia 70cc tah-t is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.The syncardia tah-t system is intended for use inside and outside the hospital.Investigation summary: intermacs patient registry data collected between april 1, 2014 and september 30, 2017 regarding adverse events was retrospectively reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.These events were assessed and are being reported in response to an update to the mdr complaint sources.With a review of the available information, there is no evidence of a device malfunction or performance issues that would impact the reported events.Possible clinical factors that may have contributed to these events include the patients pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulants, antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to these events.This device is used for treatment, not diagnosis.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4); (b)(6).
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Event Description
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While supported by the tah-t, the patient has experienced the following adverse events as defined by intermacs: 8 days post implant - renal dysfunction; 10 days post implant - bleeding; 25 days post implant - bleeding; 45 days post implant - wound dehiscence; 44 days post implant - respiratory failure; 45 days post implant - infection/location: unknown/type: unknown.As of (b)(6) 2017 it was reported that the patient was still supported by the tah-t.
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Manufacturer Narrative
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Additional information has been provided in section b5 and h6.Intermacs patient registry data collected from (b)(6) 2021 through (b)(6), 2022 regarding adverse events was reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.(b)(6), (di_120) follow-up report 1.
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Event Description
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During the last reporting period, it was reported that the patient had experienced the following adverse events as defined by intermacs.7 days post implant - hemolysis.7 days post implant - right heart failure.31 days post implant - hemolysis.As of march 31, 2022, it was reported that the patient was still supported by the tah-t.
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Event Description
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While supported by the tah-t, the patient experienced the following adverse events as defined by intermacs.8 days post implant - renal dysfunction.7 days post implant - hemolysis.7 days post implant - right heart failure.10 days post implant - bleeding.25 days post implant - bleeding.31 days post implant - hemolysis.44 days post implant - respiratory failure.45 days post implant - infection i location unknown i type: unknown.45 days post implant - wound dehiscence.The patient subsequently expired with a cause of death listed as end-stage cardiomyopathy after 105 days of tah-t support.
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Manufacturer Narrative
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The syncardia 50cc or 70cc temporary total artificial heart (tah-t) is an implantable pulsatile biventricular replacement device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation systems.The syncardia 50cc or 70cc tah-t is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.The syncardia tah-t system is intended for use inside and outside the hospital.Investigation summary: intermacs patient registry data collected from (b)(6), 2022 through (b)(6), 2022 regarding adverse events was reviewed.Patients were de-identified therefore a one-ton-one correlation could not be made between the patient and the lot number of the implanted heart.With a review of the available information, there is no evidence of a device malfunction or performance issues that would impact the reported events.Possible clinical factors that may have contributed to these events include the patients pre-existing history and related comorbidities (see section b7), the progression of their underlying disease, issues related to the therapeutic use of anticoagulants, antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to these events.This device is used for treatment, not diagnosis.Emdr (b)(4) follow-up report 2.
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Search Alerts/Recalls
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