BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 9677030 · Received February 6, 2020

    Report

    Report Number
    2916596-2020-00656
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    November 16, 2013
    Report Date
    March 18, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT'S INFECTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED GI BLEED AND DEPRESSION COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT HAS CORONARY ARTERY DISEASE (CAD) AND ISCHEMIC CARDIOMYOPATHY (ICM), WHICH WAS COMPLICATED BY A DRIVELINE INFECTION ON (B)(6) 2013. THE PATIENT¿S DRIVELINE WAS POSITIVE FOR PROTEUS MIRABILIS AND THE PATIENT WAS PLACED ON DOXYCYCLINE 100 MG TWICE A DAY (BID). THE PATIENT ALSO SUFFERED FROM DEPRESSION. IN ADDITION, THE PATIENT HAD A HISTORY OF GI BLEEDING FROM 2013. THE ACCOUNT LATER COMMUNICATED THROUGH A TELEPHONE CALL STATING THAT PER INFECTIOUS DISEASE, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE ISSUE RESOLVED. THE PATIENT¿S GI BLEED WAS ALSO STABLE AND REQUIRED NO TREATMENT. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). THE HMII LVAS IFU LISTS BLEEDING AND INFECTION (DRIVELINE, PUMP POCKET, AND LOCAL) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE IFU LISTS PSYCHOSOCIAL ISSUES AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THIS IFU ALSO PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THERE IS A RISK OF BLEEDING. THIS IFU, AS WELL AS THE HMII LVAS PATIENT HANDBOOK, ALSO PROVIDE INFORMATION REGARDING HOW TO PREVENT INFECTION AND HOW TO CARE FOR THE DRIVELINE EXIT SITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS CORONARY ARTERY DISEASE (CAD)AND ISCHEMIC CARDIOMYOPATHY (ICM). REPORTED THAT (B)(6) 2013 COMPLICATED BY DRIVE LINE INFECTION (DLI), POSITIVE FOR PROTEUS MIRABILIS, ON DOXYCYCLINE 100 MG TWICE A DAY. THE PATIENT ALSO SUFFERED GASTROINTESTINAL BLEEDING (GIB) AND DEPRESSION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139579 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R