BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22110422 · Received May 29, 2025

    Report

    Report Number
    2916596-2025-03191
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    March 29, 2025
    Report Date
    July 28, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS SAME AS PUBLISHED DATE, 29MAR2025, SINCE THE DATE OF IMPLANT OR DATA COLLECTION WAS NOT PROVIDED. SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. SECTION D6A: DATE OF EXPLANT WAS NOT PROVIDED. AUTHOR INFORMATION: BOBBA, V., DAHAL, A., COTTS, W., GRANEY, B., GRANEY, N., KUPER, K., PALIGA, R., MACALUSO, G. P., TATOOLES, A., CHAU, V., COTTS, W. G., & NARANG, N. (2025). A LONG STRANGE ROAD TO HEART TRANSPLANTATION IN A PATIENT WITH HEARTMATE 3 LVAD. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 85(12), 3359. HTTPS://DOI.ORG/10.1016/S0735-1097(25)03843-4. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4: MODEL AND CATALOG NUMBERS CORRECTED SECTION E1: REPORTER EMAIL WAS NOT AVAILABLE. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE REPORT OF LOW FLOW ALARMS COULD NOT BE CONFIRMED AS NO LOG FILES WERE SUBMITTED FOR REVIEW. A SPECIFIC CAUSE FOR THE LOW FLOW ALARMS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS BLEEDING AND INFECTION (LOCAL, DRIVELINE, AND PUMP POCKET) AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 1 OF THE IFU ALSO ADDRESSES ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. SECTION 4 OF THE IFU, ¿HEARTMATE TOUCH COMMUNICATION SYSTEM¿, DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. IT ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITION CAN RESULT IN LOW FLOW. PER DESIGN, WHEN THE ESTIMATED FLOW VALUE IS CALCULATED AT LESS THAN 2.5 LITERS PER MINUTE (LPM), A LOW FLOW STATUS IS POSTED TO THE LOG FILE. IF THE FLOW REMAINS BELOW 2.5 LPM FOR 10 SECONDS, A LOW FLOW HAZARD ALARM IS TRIGGERED. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. SECTION 6 OF THE IFU ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, OUTLINES ALL SYSTEM ALARM CONDITIONS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION, AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "A LONG STRANGE ROAD TO HEART TRANSPLANTATION IN A PATIENT WITH HEARTMATE 3 LVAD" THAT HEARTMATE 3 MAY BE RELATED TO TRANSIENT ISCHEMIC ATTACKS AND INFECTION. THIS CASE STUDY PRESENTED A 52-YEAR-OLD MALE WITH ISCHEMIC CARDIOMYOPATHY WHO UNDERWENT HEARTMATE 3 (HM3) IMPLANTATION AS A BRIDGE-TO-CANDIDACY. THE PATIENT PRESENTED 4 MONTHS POST-IMPLANT WITH ACUTE LOW FLOW ALARMS AND FLOWS < 1 L/MIN. ATTEMPTS AT RAMPING UP THE DEVICE TO INCREASE FLOWS WERE UNSUCCESSFUL; PLASMA FREE HEMOGLOBIN AND LACTATE DEHYDROGENASE WERE NORMAL. CARDIAC COMPUTED TOMOGRAPHY (CT) DEMONSTRATED NO OCCLUSION IN THE OUTFLOW GRAFT OR PANNUS/MOBILE CLOT AT THE INFLOW CANNULA. CONTROLLER EXCHANGE AND INOTROPIC THERAPY DID NOT CHANGE FLOWS. A RAMP STUDY WAS PERFORMED WHILE HEPARINIZED, WITH BASELINE FLOWS OF 1.5 L AT 5800 RPM, INCREASING TO 9000 RPM AND THEN DOWN TO 5800 RPM WITH A NADIR OF 3600 RPM TO CONFIRM RETROGRADE FLOW VIA ECHOCARDIOGRAM. THE AORTIC VALVE OPENED THROUGHOUT. FOLLOWING THE RAMP STUDY, SPEED WAS RESET TO 5800 RPM, RESTORING NORMAL FLOW OF 4.6 L/MIN. TWO MONTHS LATER, THE PATIENT PRESENTED WITH A TRANSIENT ISCHEMIC ATTACK (TIA) AND WAS FOUND TO HAVE STREPTOCOCCUS MITIS BACTEREMIA. CTA OF THE HEAD REVEALED A LEFT CEREBRAL ARTERY MYCOTIC ANEURYSM, WHICH WAS COILED. THE PATIENT RECEIVED INTRAVENOUS AMPICILLIN AND SUPPRESSIVE AMOXICILLIN. GIVEN TWO CRITICAL COMPLICATIONS, THE PATIENT UNDERWENT TRANSPLANT (OHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26019 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Life Threatening| R