BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8723978 · Received June 21, 2019

    Report

    Report Number
    2916596-2019-02963
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    May 20, 2019
    Report Date
    August 21, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. IN ADDITION, THE ANALYSIS OF THE SUBMITTED LOG FILES DID NOT REVEAL ANY LOW FLOW ALARMS; HOWEVER, MULTIPLE PI EVENTS WERE CONFIRMED. A SPECIFIC CAUSE FOR THE PI EVENTS COULD NOT BE DETERMINED. THE SUBMITTED SYSTEM CONTROLLER EVENT LOG FILES CONTAINED DATA ON (B)(6) 2019 AND ON (B)(6) 2019. NO LOW FLOW EVENTS WERE NOTED WITHIN THE FILES; HOWEVER, MULTIPLE PI EVENTS WERE OBSERVED. THE SYSTEM CONTROLLER EVENT AND REMAINING LOG FILES SHOWED THAT THE PUMP APPEARED TO FUNCTION AS INTENDED. THE HEARTMATE 3 LVAS IFU LISTS PUMP THROMBOSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. ADDITIONALLY, THIS DOCUMENT DESCRIBES ALL ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HM3 IFU EXPLAINS THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS AND MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. THIS DOCUMENT ALSO STATES THAT THERE ARE NO AUDIBLE ALARMS WITH A PI EVENT AND EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR AND LEFT VENTRICULAR FILLING. LASTLY, THE DOCUMENT PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 ¿ 1 YEAR 8 MONTHS (THE AGE IS CALCULATED FROM THE DATE OF IMPLANT TO THE EVENT DATE.). THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. 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 THE PATIENT WAS ADMITTED WITH CHEST PAIN, DIZZINESS, HIGH PULMONARY INDEX (PI), AND LOW FLOWS ON (B)(6). LOG FILES WERE SENT FOR REVIEW. THE LOG FILE ANALYSIS SHOWED THAT THERE WERE NO NOTABLE ALARM CONDITIONS OR PARAMETER CHANGES. THE MCS DEVICE APPEARED TO BE WORKING AS INTENDED. ON (B)(6) 2019, CARDIAC CT ANGIOGRAPHY (CTA), BEDSIDE ECHOCARDIOGRAM SHOWED SMALL LEFT VENTRICLE (LV) ON (B)(6) 2019. SPEED WAS DECREASED TO 5500 ON (B)(6) 2019; BEDSIDE ECHO SHOWED IMPROVED LV SIZE. ON (B)(6) 2019, PATIENT WAS DISCHARGED HOME HEMODYNAMICALLY STABLE. PATIENT HAD KNOWN AORTIC ROOT THROMBUS AND HAD RECENT NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). PATIENT HAD BRIEF EPISODE OF CHEST PAINT YESTERDAY. LOG FILE WAS REVIEWED BY TECH SERVICES; THE EVENT LOG CAPTURED PERSISTENT PI EVENTS, BUT NOTHING UNUSUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518013 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6078489

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L