BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 17863140 · Received October 3, 2023

    Report

    Report Number
    2916596-2023-07212
    Event Type
    Death
    Date Received
    October 3, 2023
    Date of Event
    April 30, 2022
    Report Date
    December 12, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED PATIENT DEATHS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE AND WERE NOT REQUESTED. THE HEARTMATE 3 LVAS IFU, REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT IS APPROXIMATE AS THE DATA WAS COLLECTED BETWEEN (B)(6) 2022. (B)(6). RELATED MFR 2916596-2023-07171. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿OUTCOME OF PATIENTS SUPPORTED WITH HEARTMATE 3 AFTER EXTRA-CORPOREAL LIFE SUPPORT. ON BEHALF OF DURABLE MCS AFTER ECLS STUDY GROUP¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH RIGHT HEART FAILURE, STROKE, MULTISYSTEM ORGAN FAILURE, BLEEDING, DRIVELINE INFECTION, PUMP THROMBOSIS, AND DEATH. THIS RETROSPECTIVE STUDY ASSESSED THE OUTCOMES OF PATIENTS IMPLANTED WITH HM3 FOLLOWING EXTRA-CORPOREAL LIFE SUPPORT (ECLS) FROM (B)(6) 2016 THROUGH (B)(6) 2022 ACROSS 14 CENTERS. A TOTAL OF 337 PATIENTS BRIDGED TO MECHANICAL CIRCULATORY SUPPORT (MCS) WERE INCLUDED IN THE STUDY. 140 OF THESE PATIENTS WERE IMPLANTED WITH HM3, AND THEIR OUTCOMES WERE COMPARED TO 197 PATIENTS IMPLANTED WITH OTHER PUMPS, INCLUDING MEDTRONIC HVAD AND HEARTMATE II. RESULTS FOUND THAT 47% OF HM3 PATIENTS AND 39% OF OTHER MCS PATIENTS HAD RIGHT VENTRICULAR FAILURE POSTOPERATIVELY, REQUIRING A TEMPORARY RIGHT VENTRICULAR ASSIST DEVICE (RVAD) (P= 0.2); HM3 PATIENTS WERE ON RVAD SUPPORT FOR AN AVERAGE OF 15 DAYS. HM3 PATIENTS WERE NOTED TO HAVE A LOWER CHEST TUBE OUTPUT (900 VS 1195 ML, P = 0.03). HM3 PATIENTS WERE ALSO NOTED TO HAVE SIGNIFICANTLY LOWER POSTOPERATIVE STROKE (16% VS. 28%, P = 0.01) AND PUMP THROMBOSIS (3% VS. 8%, P = 0.02). RE-EXPLORATION FOR BLEEDING WAS REQUIRED FOR 26% OF HM3 PATIENTS AND 57% OF OTHER MCS PATIENTS; THE ADMINISTRATION OF FRESH FROZEN PLASMA (FFP), RED BLOOD CELL PACKS (RBC), AND PLATELETS WAS COMPARABLE BETWEEN THE TWO GROUPS. POSTOPERATIVE GASTROINTESTINAL BLEEDING WAS OBSERVED IN 12% OF HM3 PATIENTS AND 17% OF OTHER MCS PATIENTS. POSTOPERATIVE DRIVELINE INFECTIONS WERE OBSERVED IN 32% OF HM3 PATIENTS AND 27% OF OTHER MCS PATIENTS. THE 30-DAY, 1-YEAR, AND 3-YEAR SURVIVAL RATE OF THE HM3 GROUP WAS 87%, 73%, AND 65%, RESPECTIVELY, COMPARED TO THE OTHER MCS GROUP SURVIVAL RATE OF 81%, 56%, AND 48%, RESPECTIVELY. MULTISYSTEM ORGAN FAILURE WAS THE LEADING CAUSE OF DEATH FOR BOTH GROUPS, ACCOUNTING FOR 45% OF HM3 PATIENT DEATHS AND 59% OF OTHER MCS PATIENT DEATHS. THE AVERAGE MCS SUPPORT DURATION WAS 11 MONTHS FOR HM3 PATIENTS AND 13 FOR OTHER MCS PATIENTS (P = 0.8). LEFT VENTRICULAR RECOVERY LEADING TO DEVICE EXPLANT WAS OBSERVED IN 3% OF HM3 PATIENTS AND 4% OF OTHER MCS PATIENTS (P 0.9). HEART TRANSPLANT WAS LISTED AS AN OUTCOME FOR 15% OF HM3 PATIENTS AND 18% OF OTHER MCS PATIENTS, BUT NO FURTHER INFORMATION WAS GIVEN REGARDING THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414360 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) DEVICE DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death