BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10079393 · Received May 21, 2020

    Report

    Report Number
    2916596-2020-02712
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    February 29, 2020
    Report Date
    August 27, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER: (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT THE PATIENT ADMITTED ON (B)(6) 2020 FOR GASTROINTESTINAL (GI) BLEEDING, CHRONIC ANEMIA, AND MELENA. THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY WHICH REVEALED HIATAL HERNIA WITH CAMERON'S EROSIONS. THE PATIENT ALSO EXPERIENCED SYMPTOMS OF MELENA, CHRONIC FATIGUE, AND THE CHRONIC ANEMIA WHICH REQUIRED BLOOD TRANSFUSIONS. THE ENDOSCOPY PROCEDURES REVEALED NO SPECIFIC SOURCE AVAILABLE FOR INTERVENTION. THE PATIENT CONTINUED ON DANAZOL, PROTON PUMP INHIBITOR TWICE DAILY (PPI BID), ASPIRIN (ASA) AND WAS DISCHARGED. THE PATIENT WAS TREATED WITH IRON INTRAVENOUSLY (IV) WHILE AN INPATIENT. THE PATIENT GOAL WAS LOWERED TO 1.4-1.8 AND VITAMIN K 100MCG WAS PRESCRIBED DAILY BEFORE MEALS. AFTER-LOAD REDUCTION WAS STRICTLY MONITORED AND LISINOPRIL WAS INCREASED. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2020. THE HEARTMATE 3 LVAD, SERIAL NUMBER: (B)(6), WAS NOT RETURNED FOR EVALUATION (PER-2020-0092746/CS-138042). THE HEARTMATE 3 LVAS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES, AND THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2020 FOR A GASTROINTESTINAL (GI) BLEED AND ANEMIA. IT WAS REPORTED THAT THE GI BLEEDING WAS CONFIRMED AND THE PATIENT WAS ALSO ADMITTED FOR CHRONIC ANEMIA AND MELENA. THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY WHICH REVEALED HIATAL HERNIA WITH CAMERON'S EROSIONS. THE PATIENT EXPERIENCED SYMPTOMS OF MELENA, CHRONIC FATIGUE, AND CHRONIC ANEMIA WHICH REQUIRED BLOOD TRANSFUSIONS. THE ENDOSCOPY PROCEDURES UNVEILED NO SPECIFIC SOURCE AVAILABLE FOR INTERVENTION. THE PATIENT CONTINUED ON DANAZOL, PROTON PUMP INHIBITOR TWICE DAILY (PPI BID), ASPRIN (ASA) AND WAS DISCHARGED (D/C). THE PATIENT WAS GIVEN IRON INTRAVENOUSLY (IV) WHILE AN INPATIENT. PATIENT GOAL LOWERED TO 1.4-1.8 AND VITAMIN K 100MCG WAS PRESCRIBED DAILY BEFORE MEALS. AFTER-LOAD REDUCTION WAS STRICTLY MONITORED AND LISINOPRIL WAS INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545010 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6160219 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R