BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8222043 · Received January 7, 2019

    Report

    Report Number
    2916596-2019-00084
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    December 10, 2018
    Report Date
    April 17, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES EXPIRATION AND MANUFACTURING, RESPECTIVELY, DATES HAVE BEEN ENTERED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THIS TYPE OF EVENT HAS BEEN PREVIOUSLY INVESTIGATED. GASTROINTESTINAL BLEEDING AND STROKE IS AN EXPECTED ADVERSE EVENT RELATED TO LVAD THERAPY AND IDENTIFIED IN THE IFU. A DEVICE MALFUNCTION CANNOT BE CONFIRMED. TRENDING WILL CONTINUE TO MONITOR FOR ANY CHANGE IN PERFORMANCE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT A HEAD CT WAS PERFORMED ON (B)(6) 2018 WHICH SHOWED EVOLVING ISCHEMIC CHANGE TO RIGHT POSTERIOR PARASEPTAL REGION WITHOUT EVIDENCE OF HEMORRHAGE. ON (B)(6) 2018, PATIENT WAS STABLE WITH RIGHT HEMISPHERIC INFARACT. NO ACUTE HEMORRHAGE WAS SPOTTED. A HEAD CT ON (B)(6) 2018 AND SHOWED THAT PATIENT WAS STABLE WITH NO HEMORRHAGE.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 2 YEARS 3 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) 2016. THE PATIENT PRESENTED ON (B)(6) 2018 TO THE EMERGENCY DEPARTMENT WITH LEFT SIDED WEAKNESS WITH STROKE SCALE OF 7, IMPROVED TO 3. CTA SHOWED RIGHT M2 OCCLUSION. SHE WAS OUT OF THE TPA WINDOW. IN THE SAME ADMISSION ON (B)(6) 2018 PATIENT'S EGD SHOWED DUODENAL AVM, CAUTERIZED WITH ARGON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13973 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R