BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3893636 · Received June 10, 2014

    Report

    Report Number
    2916596-2014-00922
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE REPORTED GI BLEED AND THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. THE PATIENT REMAINS ONGOING ON VAD SUPPORT WITH NO FURTHER REPORTED ISSUES. NO PRODUCT WAS AVAILABLE FOR EVALUATION. THORATEC'S APPROVED LABELING ALSO OUTLINES APPROPRIATE ANTICOAGULATION THERAPIES. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL PM (B)(6) 2014 WITH A GI BLEED. ARTERIOVENOUS MALFORMATIONS (AVMS) AND DIVERTICULITIS WERE FOUND. THE PATIENT WAS OFF ANTICOAGULATION AND ASPIRIN. THE AVMS WERE CAUTERIZED, AND THEN PRIOR TO DISCHARGING THE PATIENT ON (B)(6) 2014, THE PATIENT WAS STARTED ON ANTICOAGULATION AND ASPIRIN FOR INR GOAL OF 1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340300 HEARTMATE II LVAS DSQ:LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115858

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention