Catalog Number 500101 |
Device Problems
Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Neurological Deficit/Dysfunction (1982); Urinary Tract Infection (2120); Respiratory Failure (2484); Patient Problem/Medical Problem (2688)
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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 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: 1 day post implant - bleeding; 6 days post implant - respiratory failure; 6 days post implant - bleeding; 17 days post implant - infection/location: positive blood cultures, other/type: bacterial; 8 days post implant - neurological dysfunction - cva/location: other/severity: left sided weakness; 6 days post implant - other sae; 99 days post implant - device malfunction and/or pump thrombosis; 99 days post implant - infection/location: urinary tract, other/type: bacterial; 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.Intermacs patient registry data collected from october 1, 2017 through december 31, 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.(b)(4) 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 event as defined by intermacs: 104 days post implant - infection i location: urinary tract i type: bacterial the patient subsequently received a heart transplant after 395 days of tah-t support.
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Manufacturer Narrative
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Additional information has been provided.Intermacs patient registry data collected from october 1, 2017 through december 31, 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.(b)(4) 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 event as defined by intermacs: 104 days post implant - infection i location: urinary tract i type: bacterial the patient subsequently received a heart transplant after 395 days of tah-t support.
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Search Alerts/Recalls
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