BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 9896984 · Received March 30, 2020

    Report

    Report Number
    2916596-2020-01791
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    December 25, 2019
    Report Date
    June 4, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: CORRECTION SECTION D4, H4: ADDITIONAL INFORMATION SECTION G4: IN THE PREVIOUSLY SUBMITTED ADDITIONAL REPORT FOR THIS EVENT, THE NOTIFICATION DATE WAS INADVERTENTLY LEFT OUT. THE DATE RECEIVED BY MANUFACTURER FOR THAT REPORT IS (B)(6)2020 . MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER(B)(6) , AND THE REPORTED RIGHT HEART FAILURE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT REPORTED THAT ON (B)(6)2019 , THE PATIENT WAS ADMITTED FOR RIGHT HEART FAILURE. THE PATIENT WAS PREVIOUSLY STARTED ON AND REMAINED ON AN INTRAVENOUS (IV) DOBUTAMINE DRIP AS AN OUTPATIENT. THE PATIENT ALSO RECEIVED IV AND ORAL (PO) DIURETIC MANAGEMENT AS AN OUTPATIENT. THE PATIENT¿S RIGHT HEART FAILURE WAS NOT CONSIDERED TO BE CAUSED BY PUMP MALFUNCTION AND THE EVENT REPORTEDLY RESOLVED ON (B)(6)2019 . THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6) . THE HMII LVAS IFU LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE DURING THE USE OF THE HEARTMATE II LVAS AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. THE IFU FURTHER CAUTIONS THAT RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP AND RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP. SECTION 6, UNDER "POSTOPERATIVE PATIENT CARE", CAUTIONS: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP." SECTION 6 (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE DURING USE OF THE HEARTMATE II LVAS AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS LONG-STANDING HEART FAILURE DUE TO ADVANCING HEART DISEASE. PATIENT WAS PREVIOUSLY AND IS CONTINUED ON DOBUTAMINE DRIP AS AN OUTPATIENT FOR RIGHT HEART FAILURE AS WELL AS IV AND ORAL DIURETIC MANAGEMENT AS AN OUTPATIENT. PATIENT'S RIGHT HEART FAILURE IS NOT FELT TO BE CAUSED BY PUMP MALFUNCTION.

    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

    PATIENT WAS ADMITTED FOR RIGHT HEART FAILURE AND REMAINED ON IV DOBUTAMINE. EVENT RESOLVED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359796 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization