BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12322617 · Received August 16, 2021

    Report

    Report Number
    2916596-2021-04526
    Event Type
    Death
    Date Received
    August 16, 2021
    Date of Event
    June 1, 2021
    Report Date
    October 19, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE REPORTED RIGHT HEART FAILURE (RHF) 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 (B)(6) 2021. THE HEARTMATE 3 LVAS INSTRUCTION FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS RIGHT HEART FAILURE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO DEVICE RELATED ISSUES THAT CAUSED OR CONTRIBUTED TO THE RIGHT HEART FAILURE (RHF). THE RHF WAS MORE RELATED TO LONG BYPASS TIME. THE RVAD (RIGHT VENTRICULAR ASSIST DEVICE) USED WAS FROM A DIFFERENT MANUFACTURER. THE TEMPORARY RVAD (RIGHT VENTRICULAR ASSIST DEVICE) USED WAS FROM A DIFFERENT MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S GENDER WAS REQUESTED, BUT YET PROVIDED. 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 THE PATIENT PASSED AWAY DUE TO RIGHT HEART FAILURE. IT WAS REPORTED THAT THE PATIENT HAD SEVERE RIGHT VENTRICULAR (RV) FAILURE AND A TEMPORARY RVAD (RIGHT VENTRICULAR ASSIST DEVICE) WAS PLACED. THE RVAD CANNULA WAS DISLODGED IN THE ICU (INTENSIVE CARE UNIT) AND RV WAS UNABLE TO RECOVER DUE TO RVAD SURGICAL COMPLICATIONS. FURTHERMORE, IT WAS REPORTED THAT THE PATIENT'S OUTCOME WAS NOT DEVICE RELATED AND THAT THE DEVICE OPERATED AS INTENDED. THERE WERE NO REPORTED DEVICE ISSUES OR MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S CAUSE OF DEATH. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224858 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7866642 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death