BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7566294 · Received June 4, 2018

    Report

    Report Number
    2916596-2018-02301
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    July 21, 2017
    Report Date
    July 26, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DATE REC'D BY MFR. A DIRECT RELATIONSHIP BETWEEN THE HMII LVAS (B)(4) AND THE REPORTED EVENT COULD NOT BE DETERMINED. AN ENTEROSCOPY FOUND AN ACTIVE BLEEDING ANGIOECTASIA AND DIEULAFOY LESSION IN THE PROXIMAL JEJUNUM AND WAS TREATED WITH TWO ENDOCLIPS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. NO FURTHER ISSUES HAVE BEEN REPORTED. BLEEDING IS LISTED (IN THE HEARTMATE II IFU) AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT CARE AND MANAGEMENT SECTION PROVIDES INFORMATION ON ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. NO UPDATE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 1 MONTHS. THE PATIENT REMAINS ONGOING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    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 ON (B)(6) 2017 GASTROENTEROLOGY WAS ASKED TO SEE PATIENT FOR NORMALCY ANEMIA WITH A DROP IN HEMOGLOBIN DIFFERENTIAL DIAGNOSIS (DDX). GASTROINTESTINAL (GI) BLOOD LOSS FROM PEPTIC ULCER DISEASE, EROSIVE GASTRITIS, NASOGASTRIC (NG) TUBE TRAUMA AND ARTERIOVENOUS MALFORMATION (AVMS). ON (B)(6) 2017, AN ESOPHAGOGASTRODUODENOSCOPY CAME BACK WITH NEGATIVE RESULTS. ON (B)(6) 2017, AN ENTEROSCOPY FOUND BLEEDING OF THE ANGIO ECTASIA VS DIELAFOY IN PROXIMAL JEJUNUM TREATED WITH TWO ENDOCLIPS. ON (B)(6) 2017, GI SIGNED OFF ON IN PATIENT HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408237 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R