BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 8734904 · Received June 26, 2019

    Report

    Report Number
    3007042319-2019-07470
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    April 17, 2019
    Report Date
    August 2, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ OUTFLOW GRAFT. MODEL #: 1125 / CATALOG #: 1125 / EXPIRATION DATE: 31-OCT-2021 / LOT#: 15942223-9483, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 31-OCT-2016. LABELED FOR SINGLE USE: YES. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) AND OUTFLOW GRAFT WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED A DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING (B)(6) 2019. ADDITIONAL DECREASES IN POWER CONSUMPTION AND ESTIMATED FLOWS WERE LOGGED ON (B)(6) 2019. 32 LOW FLOW ALARMS WERE LOGGED SINCE (B)(6) 2019. AS A RESULT, THE REPORTED LOW FLOW EVENT WAS CONFIRMED. OF NOTE, IT WAS REPORTED THAT THE OUTFLOW GRAFT HAD COLLAPSED AT THE ANASTOMOSIS SITE. BASED ON RISK DOCUMENTATION AND THE AVAILABLE INFORMATION, POSSIBLE CAUSES OF THE LOW FLOW EVENTS MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO POOR VAD FILLING, THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. ADDITIONAL PRODUCTS: LOT#: 15942223-9483, DEVICE EVALUATED BY MFR: YES. LABEL FOR SINGLE USE: NO. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXCHANGE OF THE VENTRICULAR ASSIST DEVICE (VAD), THE SURGEON HAD KEPT A PORTION OF THE OUTFLOW GRAFT FROM THE PREVIOUS DEVICE AND ANASTOMOSED IT TO THE NEW OUTFLOW GRAFT. THE VAD HAD LOW FLOWS WHICH TRIGGERED ALARMS. UPON DIAGNOSTIC IMAGING, IT WAS NOTED THAT THE OUTFLOW GRAFTS HAD COLLAPSED AT THE ANASTOMOSES SITE OF THE TWO GRAFTS. DUE TO THE OCCLUSION, THE PATIENT EXPERIENCED LACK OF PERFUSION TO THE KIDNEYS WHICH RESULTED IN ONGOING DIALYSIS. THE OUTFLOW GRAFT WAS REPLACED AND THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526784 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R