BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20684098 · Received November 14, 2024

    Report

    Report Number
    2916596-2024-07264
    Event Type
    Death
    Date Received
    November 14, 2024
    Date of Event
    October 28, 2024
    Report Date
    December 12, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E3 - OCCUPATION: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PUMP WAS NOT RETURNED FOR 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 HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, RESPIRATORY FAILURE, AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LVAS. 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 INOTROPES AND 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE VENTRICULAR ASSIST DEVICE (VAD) WAS TURNED OFF AND THE PATIENT HAD RESPIRATORY FAILURE. THERE WAS AN UNCLEAR REASON FOR QUICK DETERIORATION. THE PATIENT HAD A HISTORY OF RIGHT HEART FAILURE. THIS DEATH WAS NOT CONSIDERED TO BE DEVICE RELATED. THE DEVICE OPERATED AS EXPECTED. THE RIGHT HEART FAILURE DID NOT EXIST PRE-VAD IMPLANT. IT WAS UNKNOWN WHETHER THE DEVICE CONTRIBUTED TO RIGHT HEART FAILURE. THE PATIENT WAS NOT SYMPTOMATIC OF RIGHT HEART FAILURE IN THE YEARS LEADING UP TO THEIR LAST FEW DAYS. THE FAMILY DID NOT WANT TO PURSUE MORE AGGRESSIVE TREATMENT AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197202 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6476692 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death