BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8647340 · Received May 28, 2019

    Report

    Report Number
    2916596-2019-02366
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    February 8, 2017
    Report Date
    October 11, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION. SECTION H4: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE REPORTED LOW FLOWS, ATRIAL FIBRILLATION, AND HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4) COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE REPORTED EVENTS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE SENT TO THE ACCOUNT; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4) AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE HM3 LVAS IFU LISTS CARDIAC ARRHYTHMIA AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE IFU ALSO EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW AND THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THE IFU ALSO DESCRIBES ALL ALARM CONDITIONS, INCLUDING THE LOW FLOW HAZARD, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE ATRIAL FIBRILLATION WAS DETERMINED TO BE RELATED TO THE DEVICE AND THE PATIENT IS ON LONG TERM AMIODARONE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: THE PATIENT WAS REPORTEDLY HAVING LOW FLOW ALARMS PRIOR TO ICD INTERROGATION.

    Additional Manufacturer Narrative · 1

    BRAND NAME, UDI #: THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING (B)(6) TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE- 7 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT ICD INTERROGATION REVEALED THE PATIENT HAD MORE THAN 9 HOURS OF ATRIAL FIBRILLATION (AFIB). THE PATIENT'S HEART RATE WAS IN THE 130S BPM. THE PATIENT WAS GIVEN AMIODARONE BOLUS 150MG AND RATE CONTROL IMPROVED. THE PATIENT HAD A HISTORY OF AFIB AND TREATMENT CHANGED TO AMIODARONE TAKEN ORALLY ON (B)(6) 2017 AND THE EVENT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438924 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 5820866

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other