BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA 50CC OR 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

    MDR report key: 11760915 · Received May 3, 2021

    Report

    Report Number
    3003761017-2021-00075
    Event Type
    Injury
    Date Received
    May 3, 2021
    Report Date
    June 22, 2023
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003008
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN SECTION B5 AND H6. INTERMACS PATIENT REGISTRY DATA COLLECTED FROM OCTOBER 1, 2020 THROUGH MARCH 31, 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. (B)(4).

    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 2.

    Additional Manufacturer Narrative · 0

    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. RA-1788 PT 122397 (DI_263) FOLLOW-UP REPORT 3.

    Additional Manufacturer Narrative · 0

    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 OCTOBER 01, 2022 THROUGH DECEMBER 31, 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 PT 122397 (DI_263) FOLLOW-UP REPORT 4.

    Description of Event or Problem · 0

    SINCE THE LAST REPORTING PERIOD, THE PATIENT EXPERIENCED THE FOLLOWING ADVERSE EVENT AS DEFINED BY INTERMACS: 305 DAYS POST IMPLANT - DEVICE MALFUNCTION AND/OR PUMP THROMBOSIS. AS OF MARCH 31, 2021, IT WAS REPORTED THAT THE PATIENT WAS STILL SUPPORTED BY A TAH-T.

    Description of Event or Problem · 0

    SINCE THE LAST REPORTING PERIOD, THE PATIENT EXPERIENCED THE FOLLOWING ADVERSE EVENTS AS DEFINED BY INTERMACS: 400 DAYS POST IMPLANT - DEVICE MALFUNCTION AND/OR PUMP THROMBOSIS. 404 DAYS POST IMPLANT - DEVICE MALFUNCTION AND/OR PUMP THROMBOSIS. AS OF (B)(6) 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. 20 DAYS POST IMPLANT - HEMOLYSIS. 20 DAYS POST IMPLANT - HYPERTENSION. 20 DAYS POST IMPLANT - HYPERTENSION. 20 DAYS POST IMPLANT - INFECTION. 21 DAYS POST IMPLANT - HYPERTENSION. 24 DAYS POST IMPLANT - HEMOLYSIS. 33 DAYS POST IMPLANT - HEMOLYSIS. 90 DAYS POST IMPLANT - HEMOLYSIS. 344 DAYS POST IMPLANT - HEMOLYSIS. 561 DAYS POST IMPLANT - HEMOLYSIS. 561 DAYS POST IMPLANT - RIGHT HEART FAILURE. AS OF (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT WAS STILL SUPPORTED BY THE TAH-T.

    Description of Event or Problem · 0

    DURING THE LAST REPORTING PERIOD, IT WAS REPORTED THE PATIENT EXPERIENCED THE FOLLOWING ADVERSE EVENTS AS DEFINED BY INTERMACS: 838 DAYS POST IMPLANT - DEVICE MALFUNCTION AND/OR PUMP THROMBOSIS. AS OF (B)(6) 2022 IT WAS REPORTED THAT PATIENT WAS STILL SUPPORTED BY THE TAH-T.

    Additional Manufacturer Narrative · 1

    THE SYNCARDIA 70 CC 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 70 CC 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)(6).

    Description of Event or Problem · 1

    WHILE SUPPORTED BY THETAH-T, THE PATIENT HAS EXPERIENCED THE FOLLOWING ADVERSE EVENTS AS DEFINED BY INTERMACS: 5 DAYS POST IMPLANT - RENAL DYSFUNCTION. 212 DAYS POST IMPLANT - RENAL DYSFUNCTION. 217 DAYS POST IMPLANT - PSYCHIATRIC EPISODE. 281 DAYS POST IMPLANT - INFECTION I LOCATION PUMP/RELATED - DRIVE LINE I TYPE: BACTERIAL. 294 DAYS POST IMPLANT - DEVICE MALFUNCTION AND/OR PUMP THROMBOSIS. 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
    658020 SYNCARDIA 50CC OR 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 50CC OR 70CC 00858000003008

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other