BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA 70CC TOTAL ARTIFICIAL HEART (STAH)

    MDR report key: 22379036 · Received July 1, 2025

    Report

    Report Number
    3003761017-2025-00120
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 29, 2025
    Report Date
    September 15, 2025
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003008
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT STAH LOT NUMBER: 130338 (RIGHT VENTRICLE ID: (B)(6)) WAS SERVICED AND PASSED ALL FUNCTIONAL TESTING PRIOR TO BEING RELEASED TO FINISHED GOODS ON 02 APR 2025. VISUAL INSPECTION OF DEVICE FOUND NO ABNORMALITIES AROUND THE INFLOW VALVE, INFLOW QUICK CONNECT, AND OUTER SLEEVE. AN AIR BUBBLE WAS FOUND AROUND THE JUNCTION AREA BETWEEN THE QUICK CONNECT OUTER SLEEVE FOR OUTFLOW VALVE BUT WAS NOT OF SIGNIFICANCE AND DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. THE RIGHT STAH VENTRICLE PASSED ALL FUNCTIONAL TESTING DURING INITIAL EXPLANT ANALYSIS. A NON-CLINICAL INFLOW CONNECTOR WAS UTILIZED TO TEST LATCHING ABILITY TO INFLOW OUTER SLEEVE, AND FOR LEAKS WHEN RUNNING WATER FROM A FAUCET INTO THE CONNECTOR. INFLOW CONNECTOR WAS ABLE TO BE ATTACHED WITHOUT ISSUES AND KEPT A FIRM GRIP ON INFLOW OUTER SLEEVE. WITH INFLOW CONNECTOR ATTACHED, WATER FLOWED VERTICALLY ONTO JUNCTION BETWEEN INFLOW VALVE AND INFLOW OUTER SLEEVE AT DIFFERENT ANGLES. NO WATER DROPS OR LEAKS COULD BE DETECTED AT ANY JUNCTION. RIGHT VENTRICLE WAS SUBMERGED IN WATER ON STROKE VOLUME TEST FIXTURE TO TEST FOR LEAKS WITH INCREASING PRESSURE FROM A HAND PUMP. THE INFLOW AND OUTFLOW OUTER SLEEVE WERE COVERED. CANNULA WAS ATTACHED TO CENTER HOLE FROM THE UNDERSIDE OF STROKE VOLUME TEST FIXTURE'S LID AND SUBMERGED RIGHT VENTRICLE. NO AIR BUBBLES WERE DETECTED, INDICATING NO LEAKS. STILL UNDERWATER AND CONNECTED TO NOZZLE OF LID, RIGHT VENTRICLE WAS AIR PRESSURIZED BY HAND PUMP THROUGH THE NOZZLE ON THE TOP SIDE OF STROKE VOLUME TEST FIXTURE'S LID. WHILE ACTUATING HAND PUMP, NO AIR BUBBLES WERE DETECTED, INDICATING NO LEAKS. RIGHT VENTRICLE WAS CONNECTED TO DMC TANK AND C2 DRIVER UNDER NORMOTENSIVE CONDITIONS. NO LEAKS WERE DETECTED, RIGHT AVERAGE CARDIAC OUTPUT WAS WITHIN SPECIFICATIONS, AND PRESSURE OUTPUTS REMAINED NORMOTENSIVE. FAILURE INVESTIGATION FOR THIS COMPLAINT COULD NOT CONFIRM THE REPORTED ISSUE. THE CUSTOMER COMPLAINT WAS NOT REPLICATED; THE ROOT CAUSE OF THE REPORTED LEAKING RIGHT STAH VENTRICLE COULD NOT BE DETERMINED. FAILURE INVESTIGATION IDENTIFIED NO TEST FAILURES OR DAMAGE THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE AIR BUBBLE FOUND AT THE JUNCTION OF THE OUTFLOW CONNECTOR AND THE VENTRICLE WAS COSMETIC ONLY. NO EVIDENCE OF A DEVICE MALFUNCTION WAS FOUND AND THE STAH FUNCTIONED AS INTENDED. THE PATIENT WAS PLACED BACK ON BYPASS SUPPORT AND THEN IMPLANTED WITH A REPLACEMENT RIGHT VENTRICLE. NO ADVERSE IMPACT TO PATIENT REPORTED. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER COMPLAINT PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. IF NEW OR ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, SYNCARDIA WILL FILE A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 0

    DEVICE HAS NOT BEEN RECEIVED FOR EXPLANT ANALYSIS AT THE TIME OF THIS REPORT BUT WILL BE EVALUATED IMMEDIATELY UPON RETURN.

    Description of Event or Problem · 0

    PER THE IMPLANTING HOSPITAL STAFF, THE PATIENT WAS INITIALLY IMPLANTED WITH RIGHT AND LEFT VENTRICLES FROM TAH-T KIT (SN: (B)(6)), DEVICE WAS TURNED ON, BYPASS TURNED OFF. SURGEON NOTED BLOOD "LEAKING" FROM RIGHT VENTRICLE. BLOOD NOTED TO BE COMING OUT OF RIGHT VENTRICLE NEAR THE INFLOW CONNECTOR/VALVE. PATIENT PLACED BACK ON BYPASS, TAH TURNED OFF. RIGHT VENTRICLE (ID (B)(6)) REMOVED FROM PATIENT. NEW IMPLANT KIT OBTAINED (SN (B)(6)) AND NEW RIGHT VENTRICLE ( ID: (B)(6)) IMPLANTED. PATIENT WAS ULTIMATELY SUCCESSFULLY IMPLANTED AFTER BEING PLACED BACK ON BYPASS, THEN REPLACEMENT VENTRICLE WAS IMPLANTED AND PATIENT TAKEN OFF BYPASS, FULLY SUPPORTED ON THE TAH. NO OTHER ADVERSE IMPACT TO PATIENT WAS REPORTED.

    Description of Event or Problem · 0

    PER THE IMPLANTING HOSPITAL STAFF, THE PATIENT WAS INITIALLY IMPLANTED WITH RIGHT AND LEFT VENTRICLES FROM TAH-T KIT (SN: (B)(6), DEVICE WAS TURNED ON, BYPASS TURNED OFF. SURGEON NOTED BLOOD "LEAKING" FROM RIGHT VENTRICLE. BLOOD NOTED TO BE COMING OUT OF RIGHT VENTRICLE NEAR THE INFLOW CONNECTOR/VALVE. PATIENT PLACED BACK ON BYPASS, TAH TURNED OFF. RIGHT VENTRICLE (ID: 128758R0823) REMOVED FROM PATIENT. NEW IMPLANT KIT OBTAINED (SN: (B)(6) AND NEW RIGHT VENTRICLE (ID: 128924R0923) IMPLANTED. PATIENT WAS ULTIMATELY SUCCESSFULLY IMPLANTED AFTER BEING PLACED BACK ON BYPASS, THEN REPLACEMENT VENTRICLE WAS IMPLANTED AND PATIENT TAKEN OFF BYPASS, FULLY SUPPORTED ON THE TAH. NO OTHER ADVERSE IMPACT TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130561 SYNCARDIA 70CC TOTAL ARTIFICIAL HEART (STAH) BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 130338 00858000003008

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other| R