BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

    MDR report key: 11760910 · Received May 3, 2021

    Report

    Report Number
    3003761017-2021-00073
    Event Type
    Injury
    Date Received
    May 3, 2021
    Report Date
    August 16, 2022
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTERMACS PATIENT REGISTRY DATA COLLECTED FROM APRIL 1, 2021 THROUGH JUNE 30, 2021 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. CE (B)(4) PT (B)(6) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 0

    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 124167 (DI_228) FOLLOW-UP REPORT 2.

    Description of Event or Problem · 0

    DURING THE LAST REPORTING PERIOD, IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED THE FOLLOWING ADVERSE EVENT AS DEFINED BY INTERMACS: 135 DAYS POST IMPLANT - RENAL DYSFUNCTION. AS OF JUNE 30, 2021, IT WAS REPORTED THAT THE PATIENT WAS STILL SUPPORTED BY A TAH-T.

    Description of Event or Problem · 0

    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. 30 DAYS POST IMPLANT - HEMOLYSIS. 85 DAYS POST IMPLANT - HEMOLYSIS. 202 DAYS POST IMPLANT - HEMOLYSIS. 363 DAYS POST IMPLANT - HEMOLYSIS. 513 DAYS POST IMPLANT - HEMOLYSIS. 608 DAYS POST IMPLANT - INFECTION. 656 DAYS POST IMPLANT - HYPERTENSION. 653 DAYS POST IMPLANT - OTHER SAE. 653 DAYS POST IMPLANT - RENAL DYSFUNCTION. THE PATIENT SUBSEQUENTLY RECEIVED A HEART TRANSPLANT AFTER 684 DAYS OF TAH-T SUPPORT.

    Additional Manufacturer Narrative · 1

    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 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 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. (B)(4).

    Description of Event or Problem · 1

    WHILE SUPPORTED BY THETAH-T, THE PATIENT HAS EXPERIENCED THE FOLLOWING ADVERSE EVENTS AS DEFINED BY INTERMACS: 1 DAYS POST IMPLANT: BLEEDING. 1 DAYS POST IMPLANT: RENAL DYSFUNCTION. 134 DAYS POST IMPLANT: OTHER SAE. AS OF SEPTEMBER 30, 2020 IT WAS REPORTED THAT THE PATIENT WAS STILL SUPPORTED BY A TAH-T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657657 SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other