BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7136105 · Received December 20, 2017

    Report

    Report Number
    2916596-2017-03287
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 20, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, (B)(4). FDA APPROVAL FOR HEART MATE 3 LVAS WAS RECEIVED ON 23AUGUST2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING (B)(6) TRIAL. (B)(4). APPROXIMATE AGE OF DEVICE-8 MONTHS. THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT PER INFORMATION RECEIVED FROM (B)(6), MCS CLINICAL SPECIALIST UNDER CS-100712, THE PATIENT HAD A PRE-EXISTING HISTORY OF A HEMORRHAGIC CVA (PREVIOUSLY UNREPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2017, PATIENT HAD A CHANGE IN ACUTE MENTAL STATUS THAT FOLLOWED WITH LEFT SIDED PARALYSIS CHANGES WITH LEFT SIDE FLACCID. THE HEPARIN INFUSION WAS STOPPED AND A CODE CVA CALLED. THE PATIENT WAS INTUBATED AND SEDATED FOR THE PROCEDURE AND AIRWAY PROTECTION. A HEAD CT-SCAN WAS PERFORMED THAT SHOWED ACUTE RIGHT SUBARACHNOID HEMORRHAGE, RIGHT CEREBRAL SULCI ENFACEMENT AND A LEFT SIDED MIDLINE SHIFT. EDEMA FROM THE CLOT BREAKDOWN. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR AN EMERGENCY RIGHT CRANIOTOMY AND EVACUATION OF A LARGE CLOT. POST-OP COURSE, PATIENT STARTED FOLLOWING COMMANDS ON RIGHT SIDE. THE INR WAS 1.3. THE PATIENT DEVELOPED A RIGHT VENTRICULAR ASSIST DEVICE (RVAD) THROMBUS WITH A LACTATE DEHYDROGENASE LDH) AT 2000 MG/DL. THE PATIENT WAS ORDERED TO BE DO NOT RESUSCITATE (DNR). THE PATIENT HAD A URINARY TRACT INFECTION (UTI) AND ON ROCEPHIN AND CEFTAZADINE INTRAVENOUSLY FOR ANTIBIOTIC THERAPY. THE URINARY TRACT INFECTION DEVELOPED INTO PNEUMONIA. THE PATIENT RECOVERED AND WAS EXTUBATED ON (B)(6) 2017 AFTER STATUS CODE WAS FULL CODE. THE PATIENT WAS NEUROLOGICALLY INTACT AND RETURNED TO THE VAD CLINIC ON A DYSPHAGIA DIET. THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY (SNF). NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914714 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R