BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9643526 · Received January 29, 2020

    Report

    Report Number
    2916596-2020-00227
    Event Type
    Injury
    Date Received
    January 29, 2020
    Date of Event
    September 19, 2018
    Report Date
    June 23, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A CORRELATION BETWEEN MLP-011351 AND THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. DURING THE IMPLANT PROCEDURE ON (B)(6)2018 , THE PATIENT EXPERIENCED MAJOR BLEEDING. THEIR COURSE WAS ALSO COMPLICATED BY LOW FLOWS AND SLOW VENTRICULAR TACHYCARDIA, WHICH REQUIRED MULTIPLE PRESSURES AND INOTROPES. THE PATIENT WAS TRANSFUSED ONE UNIT OF BLOOD TO KEEP THE MAP AROUND 70. THE PATIENT WAS ALSO GIVEN 2 UNITS OF PLATELETS AND 2 UNITS OF FRESH FROZEN PLASMA NO ESCALATION OF PUMP SPEED WAS NOTED AND THERE WAS NO SLOW WEAN. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED WHICH REVEALED ADEQUATE CANNULA POSITIONING. APPROXIMATELY 2 DAYS POST IMPLANT, THE PATIENT EXPERIENCED FURTHER BLEEDING RELATED ISSUES. THEY WERE TRANSFUSED WITH 1 UNIT OF PACKED RED BLOOD CELLS ON (B)(6)2018 , 24SEP2018, AND THEN AGAIN ON (B)(6)2018 . THE ISSUE REPORTEDLY RESOLVED ON (B)(6)2018 . THE PATIENT REMAINED ONGOING ON VAD SUPPORT UNTIL THEY EXPERIENCED FURTHER BLEEDING RELATED ISSUES ON (B)(6)2019 (CS-133006, PER-2019-0266602). NO PRODUCT AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING AND CARDIAC ARRYTHMIA AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES. THE HEARTMATE 3 LVAS IFU DESCRIBES THE PUMP FLOW DISPLAY AND THE HAZARD ALARMS. THIS DOCUMENT 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. THE ALARMS AND TROUBLESHOOTING SECTION DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK DESCRIBES THE ACTIONS TO TAKE IN THE EVENT OF A LOW FLOW ALARM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B5: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE SITE COMMUNICATED THAT THE PATIENT WAS TRANSFUSED ONE UNIT OF PACKED RED BLOOD CELLS ON (B)(6) 2018.

    Description of Event or Problem · 0

    IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED HEART FAILURE DURING THIS TIME. NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 0

    THE SITE COMMUNICATED THAT THE PATIENT DEVELOPED A FEVER POST IMPLANT WITH MEDIASTINAL DRAINAGE. ON (B)(6)2018 AFIB WAS STARTED AND ON(B)(6)2018 AN ICD SHOCK FOR ATRIAL FIBRILLATION AND ON (B)(6) 2018 THEIR WAS ATRIAL FIBRILLATION RAPID VENTRICULAR RATE AND STARTED ON AMIO GTT. THE PATIENT RECEIVED ANTIMICROBIAL MANAGEMENT AND HAD ADDITIONAL WORKUP FOR FEVERS AND ONGOING LEUKOCYTOSIS. THEIR LEUKOCYTOSIS WAS UNCHANGED, WITH MILD BANDEMIA AND FEVER.

    Description of Event or Problem · 0

    THE SITE COMMUNICATED THAT SUBJECT WAS TRANSFUSED 1 UNIT OF PACKED RED BLOOD CELLS(PRBC) ON (B)(6) 2018, (B)(6) 2018 AND (B)(6) 2018. AS OF (B)(6) 2018 THE PATIENT REMAINED INTUBATED AND WAS UNABLE TO BE WEANED FROM VENTILATORY SUPPORT SIX DAYS POST VAD IMPLANT.

    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). NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A COMPLICATED COURSE WITH LOW FLOWS,AND SLOW VENTRICULAR TACHYCARDIA THAT REQUIRED MULTIPLE PRESSORS AND INOTROPES. PATIENT WAS TRANSFUSED ONE UNIT OF BLOOD TO KEEP MAP AROUND 70. THERE WAS NO ESCALATION OF LVAD SPEED, SLOW NO WEAN. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS DONE AND SHOWED ADEQUATE CANNULA POSITION. THE SITE IS WEANING PRESSORS AS ABLE. DURING THE LVAD IMPLANT THE SUBJECT WAS GIVEN 2 UNITS OF PLATELETS AND TWO UNITS OF FROZEN PLATELETS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108152 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 6599780

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R