BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 18348082 · Received December 18, 2023

    Report

    Report Number
    2916596-2023-08404
    Event Type
    Death
    Date Received
    December 18, 2023
    Date of Event
    November 23, 2023
    Report Date
    September 25, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: REPORTER EMAIL WAS NOT AVAILABLE. MANUFACTURER'S INVESTIGATION CONCLUSION: ADDITIONAL INFORMATION WAS RECEIVED THAT BASED ON A REVIEW OF AVAILABLE PATIENT¿S RECORD AND THE REPORTED PATIENT OUTCOME, THERE WERE NO DEVICE ISSUES AT THE TIME OF THE PATIENT OUTCOME. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. 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 COMPLETED.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED UNDER MFR # 2916596-2025-00696 AUTHOR INFORMATION VILA-GARCÍA, J., MARCO CLEMENT, I., POVEDA PINEDO, I. D., LOECHES YAGÜE, B., CID MENÉNDEZ, A., & MORENO, R. (2024). FIRST EVIDENCE OF A HEARTMATE 3 DRIVELINE INFECTION BY RHIZOPUS ARRHIZUS: A CASE REPORT. THE CANADIAN JOURNAL OF CARDIOLOGY, 40(12), 2637¿2639. HTTPS://DOI.ORG/10.1016/J.CJCA.2024.10.013. (B)(6), SPAIN. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN THIS EVENT WAS DETERMINED TO BE A SUPPLEMENTAL INFORMATION TO WHAT HAD BEEN REPORTED UNDER MFR # 2916596-2023-07650. ALL INVESTIGATIONAL FINDINGS WILL BE REPORTED UNDER MFR #2916596-2023-07650.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO INFECTION. WHETHER THE DEATH WAS DEVICE OR THERAPY RELATED WAS NOT PROVIDED BY THE CUSTOMER. THE DEVICE WAS NOT EXPLANTED AND AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿FIRST EVIDENCE OF A HEARTMATE 3 DRIVELINE INFECTION BY RHIZOPUS ARRHIZUS: A CASE REPORT¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH INFECTION AND DEATH. THIS CASE STUDY EVALUATED A 66-YEAR-OLD MALE. THE PATIENT HAD A HISTORY OF ISCHEMIC CARDIOMYOPATHY AND HAD AN IMPLANTED CARDIAC DEFIBRILLATOR. THE PATIENT HAD MULTIPLE IMMUNOSUPPRESSIVE RISK FACTORS INCLUDING TYPE 2 DIABETES, CHRONIC KIDNEY DISEASE, AND ADVANCED HEART FAILURE. THE PATIENT DEVELOPED UROSEPTIC SHOCK BEFORE THE HM3 IMPLANTATION AND WAS THUS TREATED WITH MEROPENEM FOR A PERIOD OF 10 DAYS. AFTER THE INFECTION WAS TREATED THE HM3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS IMPLANTED. DUE TO INTRAOPERATIVE RIGHT VENTRICULAR (RV) FAILURE, A RV CENTRIMAG WAS IMPLANTED. ANTIBIOTIC PROPHYLAXIS WITH DAPTOMYCIN AND CEFTAZIDIME-AVIBACTAM WAS THEN PRESCRIBED DUE FOR A OXACILLINASE-48 (OXA-48) BACTERIAL INFECTION. FOR 2 DAYS AFTER SURGERY BLEEDING THROUGH CHEST TUBES PERSISTED. 2 ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED TO CONTAIN BLEEDING. LAB TESTS REVEALED PROGRESSIVE INCREASE IN LEUKOCYTE COUNT AND C-REACTIVE PROTEIN (203.0MG/DL), IN ADDITION TO ELEVATED PROCALCITONIN LEVELS(1.08NG/DL). TO ADDRESS THE INFECTION, ANIDULAFUNGIN, DAPTOMYCIN AND CEFTAZIDIME-AVIBACTAM WERE PRESCRIBED. 10 DAYS POST IMPLANT ANTIMICROBIAL DRUGS WERE STOPPED BECAUSE OF CLINICAL IMPROVEMENT. 23 DAYS AFTER HM3 IMPLANTATION PURULENT DRAINAGE WAS OBSERVED IN STERNOTOMY WOUND. THIS WAS TREATED WITH TEICOPLANIN, CEFTAZIDIME-AVIBACTAM AND ANIDULAFUNGIN. LATER THE SAME PURULENT DRAINAGE WAS DETECTED AT THE HM3 DRIVELINE INSERTION SITE AND A SKIN ULCER APPEARED ABOVE THE DRIVELINE PATHWAY. CULTURES FROM THESE SITES IDENTIFIED R ARRHIZUS. THIS LED TO ANIDULAFUNGIN TO BE REPLACED WITH INTRAVENOUS AMPHOTERICIN B AND ORAL POSACONAZOLE. A SOFT TISSUE ULTRASOUND SHOWED PHLEGMONOUS CHANGES AROUND THE DRIVELINE WITHOUT A CLEAR ABSCESS. R ARRHIZUS WAS NOT FOUND IN BLOOD, URINE, OR BRONCHIAL ASPIRATE CULTURES. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED REVEALING VEGETATION CONSISTENT WITH IMPLANTABLE CARDIAC DEFIBRILLATOR-RELATED ENDOCARDITIS. PATIENT PASSED AWAY DUE TO SEPTIC SHOCK 33 DAYS AFTER HM3 IMPLANTATION. THE ARTICLE CONCLUDED THAT EARLY RECOGNITION AND TREATMENT OF FUNGAL INFECTIONS IN LVAD PATIENTS IS ESSENTIAL AND PROMPT INVESTIGATION OF NONSPECIFIC SYMPTOMS THAT COULD POINT TO INFECTION IS ESSENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887534 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 9110994

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death