BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 9244243 · Received October 28, 2019

    Report

    Report Number
    2916596-2019-04946
    Event Type
    Death
    Date Received
    October 28, 2019
    Date of Event
    August 25, 2015
    Report Date
    November 7, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED RIGHT VENTRICULAR FAILURE AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015. PROGRESSIVE AND CONTINUED RIGHT VENTRICULAR FAILURE RESULTED IN THE PATIENT'S EXPIRATION. THE PATIENT'S OUTCOME WAS REPORTEDLY NOT DEVICE OR THERAPY RELATED. THE DEVICE PERFORMED AS INTENDED WITH NO ABNORMAL PARAMETERS NOTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND THE COMPLAINT FILE WILL BE CLOSED ACCORDINGLY. AN AUTOPSY WAS NOT PERFORMED; THE PUMP WAS NOT EXPLANTED AND IS NOT AVAILABLE FOR EVALUATION. THE HEARTMATE II LVAS IFU LISTS RIGHT HEART FAILURE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE HEARTMATE II LVAS IFU LISTS RIGHT HEART FAILURE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "PUMP PERFORMANCE MONITORING") STATES THAT IT IS CRITICAL TO USE TRANS-THORACIC ECHO TO MONITOR THE LEFT VENTRICLE DURING SPEED ADJUSTMENTS; VERIFY THAT THE SEPTUM DOES NOT SHIFT, WHICH COULD COMPROMISE RIGHT VENTRICULAR FUNCTION. SECTION 6 (UNDER "POSTOPERATIVE PATIENT CARE") CAUTIONS: "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 LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP." SECTION 6 (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE DURING USE OF THE HEARTMATE II LVAS AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. 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

    PROGRESSIVE AND CONTINUED RIGHT VENTRICULAR FAILURE RESULTED IN THE PATIENT'S DEATH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040871 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death