BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24621622 · Received March 17, 2026

    Report

    Report Number
    2916596-2026-01273
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 13, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT WAS REQUESTED BUT NOT PROVIDED. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE DRIVELINE INFECTION COULD NOT BE DETERMINED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-041761, AND THE REPORTED CHRONIC DRIVELINE INFECTION AND HYPERTENSION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER MLP-041761. NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-041761 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING INFECTION AND HYPERTENSION, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 6 OF THE IFU, UNDER ¿BLOOD PRESSURE MANAGEMENT¿, STATES THAT POST-IMPLANTATION HYPERTENSION MAY BE TREATED AT THE DISCRETION OF THE ATTENDING PHYSICIAN. ANY THERAPY THAT CONSISTENTLY MAINTAINS MEAN ARTERIAL BLOOD PRESSURE LESS THAN 90 MILLIMETERS OF MERCURY (MMHG) SHOULD BE CONSIDERED ADEQUATE. FURTHERMORE, SEVERAL SECTIONS OF THE HM3 IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. THE CURRENT REVISION OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS READMITTED FOR CHRONIC DRIVELINE INFECTION AND HYPERTENSION. AT THIS TIME THE CENTER PERFORMED A SYSTEM CONTROLLER EXCHANGE DUE TO A BREAKDOWN IN THE POWER CABLES ON THEIR PRIMARY CONTROLLER. THEY SWAPPED THE PATIENT TO THEIR BACKUP CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679128 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 9212093 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Hospitalization