BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8149558 · Received December 10, 2018

    Report

    Report Number
    2916596-2018-05464
    Event Type
    Death
    Date Received
    December 10, 2018
    Date of Event
    November 8, 2018
    Report Date
    March 26, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 14 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    EVENT UPDATED BASED ON ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE PATIENT'S OUTCOME COULD NOT CONCLUSIVELY BE ESTABLISHED. THE HEARTMATE II IFU LISTS STROKE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2018 CAUSE OF DEATH WAS STROKE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 IT WAS COMMUNICATED BY CLINICAL SPECIALIST AND SITE STAFF THAT THE PATIENT HAD A HEMORRHAGIC STROKE. IT WAS REPORTED THAT ON (B)(6) 2018 (POD 10) ATTEMPTED TO WEAN PATIENT FROM LIGHT SEDATION AT 12PM (LKN EARLIER THAT MORNING) WHEN PATIENT WAS FOUND WITH L GAZE PREFERENCE AND NO MOVEMENT OF RUE/RLE. DIAGNOSTIC TESTING UTILIZED WAS CT SCAN. IT WAS REPORTED THAT THE FOLLOWING SYMPTOMS/TREATMENT RELATED TO THE STROKE WERE L GAZE PREFERENCE AND NO MOVEMENT OF RUE/RLE. A STROKE CODE WAS CALLED AND IT WAS DETERMINED THAT PATIENT HAD A NEW LARGE INTRAPARENCHYMAL HEMATOMA INDICATING HYPERACUTE HEMORRHAGE AND NON-CLOTTED BLOOD PRODUCTS WITH RIGHTWARD MIDLINE SHIFT. PATIENTS NEURO STATUS NEVER IMPROVED AND CARE WAS EVENTUALLY WITHDRAWN ON (B)(6) 2018. IT WAS REPORTED THAT THE PUMP WAS NOT EXPLANTED AND NONE WILL BE RETURNED FOR EVALUATION. NO AUTOPSY WAS DONE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985618 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524US 6584952 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death