BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10079317 · Received May 21, 2020

    Report

    Report Number
    2916596-2020-02711
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    January 7, 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 A GASTROINTESTINAL (GI) BLEED. THE ACCOUNT REPORTED THAT THERE WAS NO CONFIRMED GI BLEED FOR THIS ADMISSION, HOWEVER, THE PATIENT REPORTED DIZZINESS, FATIGUE, AND ANEMIA WITH HEMOGLOBIN (HGB) AT 5.1 G/DL. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS) ON ADMISSION. ALSO, NO MELENA OR HEMATOCHEZIA REPORTED PER PATIENT. THE PATIENT WAS WORKED UP WITH AN UPPER ENDOSCOPY AND PILL ENDOSCOPY, HOWEVER, NO SOURCE OF BLEEDING WAS REVEALED. THE PATIENT WAS DISCHARGED WITH HGB AT 8.2 G/DL ON (B)(6)2020 . THE CONTINUED TEAM CARE PLAN INVOLVED CONTINUED DANAZOL 100MG TAKEN ORALLY TWICE A DAY, STOPPED ACETYLSALICYLIC ACID MEDICATIONS (ASA), LOWERED INR (INTERNATIONAL NORMALIZED RATIO) GOAL TO 1.4-1.8 AND CONTINUED OUTPATIENT FOLLOW-UP EVERY 2 WEEKS. 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 · 0

    SECTION B5: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2020 FOR A GASTROINTESTINAL (GI) BLEED. IT WAS REPORTED THAT THERE WAS NO CONFIRMED GI BLEED FOR THIS ADMISSION. ANEMIA WAS NOTED WITH HEMOGLOBIN (HGB) AT 5.1 G/DL. NO MELENA OR HEMATOCHEZIA REPORTED PER PATIENT. THE PATIENT WAS WORKED UP WITH AN UPPER ENDOSCOPY AND PILL ENDOSCOPY. NO SOURCE OF BLEEDING WAS REVEALED. PATIENT SYMPTOMS INCLUDED CHRONIC ANEMIA, DIZZINESS AND FATIGUE REPORTED BY PATIENT ON ADMISSION. THE PATIENT TRANSFUSED 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS) ON ADMISSION. THE PATIENT WAS DISCHARGED WITH HGB AT 8.2 G/DL ON (B)(6) 2019. THE CONTINUED TEAM CARE PLAN INVOLVED CONTINUED DANAZOL 100MG TAKEN ORALLY TWICE A DAY, STOPPED ACETYLSALICYLIC ACID MEDICATIONS (ASA), LOWERED INR (INTERNATIONAL NORMALIZED RATIO) GOAL TO 1.4-1.8 AND CONTINUED OUTPATIENT FOLLOW-UP EVERY 2 WEEKS.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543616 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6160219 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization