BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12804799 · Received November 12, 2021

    Report

    Report Number
    2916596-2021-06333
    Event Type
    Death
    Date Received
    November 12, 2021
    Date of Event
    October 19, 2021
    Report Date
    January 6, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE PATIENT'S INFECTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 13AUG2020. REVIEW OF THE STERILIZATION AND PACKAGING DOCUMENTATION IN THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTION FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS BLEEDING, INFECTION (LOCALIZED, DRIVELINE, PUMP POCKET OR PSEUDO POCKET), SEPSIS, RENAL DYSFUNCTION, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU, INCLUDING CONTROLLING INFECTION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. C. IS ALSO CURRENTLY AVAILABLE. THIS DOCUMENT CONTAINS INFORMATION ABOUT PREVENTING INFECTION. REVIEW OF THE STERILIZATION AND PACKAGING DOCUMENTATION IN THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH AN INTERMAC 1 IMPLANT WAS READMITTED WITH STERNAL INFECTION, SEPSIS AND PLEURAL EFFUSION. THE PATIENT UNDERWENT A VIDEO-ASSISTED THORACOSCOPY COMPLICATED BY HEMOTHORAX. THE COURSE WAS COMPLICATED BY CARDIORENAL SYNDROME. REQUIRED HEMODIALYSIS (HD) BUT PATIENT REFUSED LONG TERM HD. HOSPICE CARE WAS INITIATED AND PATIENT EXPIRED ON (B)(6) 2021. THE CAUSE OF DEATH WAS NO RELATED TO LEFT VENTRICULAR ASSIST DEVICE (LVAD). LVAD WILL NOT BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702343 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 100169571 7596393

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| D| L