Catalog Number 500101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Stroke/CVA (1770); Hemolysis (1886); No Code Available (3191)
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Event Type
Injury
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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 from (b)(6) 2017 through (b)(6) 2018 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.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) initial.
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Event Description
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While supported by a tah-t, the patient has experienced the following adverse event as defined by intermacs: 9 days post implant - psychiatric episode.As of (b)(6) 2018 it was reported that the patient was still supported by a 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 july 1, 2019 through september 30, 2020 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 inmplanted tah-t.Ce 5519 pt 114611 follow-up report 1.
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Event Description
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Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 135 days post implant - device malfunction and/or pump thrombosis 280 days post implant - infection i location pump/related - drive line i type: bacterial 727 days post implant - neurological dysfunction - cva i location: unknown i severity: altered mental status 837 days post implant - infection i location pump/related - drive line i type: bacterial as of september 30, 2020 it was reported that the patient was still supported by a 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 july 1, 2021 through march 31, 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.Ra-1788 pt 114611 (di_85) follow-up report 2.
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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.232 days post implant - hemolysis.384 days post implant - hemolysis.735 days post implant - hemolysis.924 days post implant - hemolysis.1078 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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Search Alerts/Recalls
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