BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17913514 · Received October 11, 2023

    Report

    Report Number
    2916596-2023-07336
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    November 1, 2022
    Report Date
    October 26, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS RECEIVED INDICATING THIS EVENT WAS A DUPLICATE AND REPORTED IN MANUFACTURER REFERENCE NUMBER 2916596-2023-00385.

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBERS ARE DOCUMENTED AS UNKNOWN. SECTION B3: DEVICE WAS IMPLANTED 33 MONTHS PRIOR TO TIME OF EVENT. EVENT DATE WAS ESTIMATED BASED ON ARTICLE DETAILS. ARTICLE TITLE: THE HEARTMATE3 LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT SUB-OCCLUSION - A GROWING PROBLEM BUT WITH A SIMPLE SOLUTION ANNA NOWAKA CHUV, CARDIAC SURGERY, LAUSANNE, SWITZERLAND; NADIA KILANI, CHUV, CARDIOLOGY, LAUSANNE, SWITZERLAND; VANESSA TORRES CHUV, CARDIAC SURGERY, LAUSANNE, SWITZERLAND; ROGER HULLIN CHUV, CARDIOLOGY, LAUSANNE, SWITZERLAND; PATRICK YERLY CHUV, CARDIOLOGY, LAUSANNE, SWITZERLAND; CARLO MARCUCCI CHUV, ANESTHESIOLOGY, LAUSANNE, SWITZERLAND; LORENZO ROSNER CHUV, ANESTHESIOLOGY, LAUSANNE, SWITZERLAND; SEBASTIAN DEGLISE CHUV, VASCULAR SURGERY, LAUSANNE, SWITZERLAND; MATTHIAS KIRSCH CHUV, CARDIAC SURGERY, LAUSANNE, SWITZERLAND SWISS MEDICAL WEEKLY 2023;153 (SUPPL.268) WWW.SMW.CH. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE THAT A PERCUTANEOUS APPROACH TO RESOLVE OUTFLOW GRAFT OBSTRUCTION IS A SIMPLE AND SAFE SOLUTION. THIS CASE STUDY REPORTS ON THE EVENTS THAT OCCURRED ON A 69-YEAR-OLD MALE HEARTMATE 3 PATIENT, IMPLANTED FOR END STAGE ISCHEMIC CARDIOMYOPATHY. THE PATIENT WAS IMPLANTED IN (B)(6) 2020, AND 33 MONTHS AFTER IMPLANT, THE PATIENT EXPERIENCED LOW FLOW ALARMS, A DECREASED EXERCISE INTOLERANCE, AND PERIPHERAL EDEMA. TRANSTHORACIC ECHOCARDIOGRAPHY WAS PERFORMED AND SHOWED THAT THE PATIENT HAD NORMAL LEFT VENTRICULAR DIMENSIONS AND MODERATE AORTIC VALVE INSUFFICIENCY. ANGIOGRAPHY COMPUTED TOMOGRAPHY SHOWED NARROWED LUMEN OF THE OUTFLOW CANNULA DUE TO A THROMBUS IN BETWEEN THE OUTFLOW GRAFT AND BEND RELIEF. AN INVASIVE RAMP TEST WAS ALSO PERFORMED AND CONFIRMED THE THROMBUS FINDING. THE PATIENT WAS TREATED WITH PERCUTANEOUS STENTING BY AN ENDOVASCULAR APPROACH, WHICH WAS DONE USING A RIGHT TRANS CAROTID ACCESS. A CATHETER WAS PLACED RETROGRADE INTO THE OUTFLOW GRAFT, UP TO THE JUNCTION POINT BETWEEN THE PUMP HOUSING AND BEND RELIEF. IN ORDER TO PERFORM THE OPERATION, LVAD SPEED AND FLOW WERE REDUCED. UPON COMPLETION OF THE PROCEDURE, PUMP FLOW IMMEDIATELY IMPROVED. THE PATIENT WAS EXTUBATED WITHOUT NEUROLOGIC COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067220 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Required Intervention| H