BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8701330 · Received June 14, 2019

    Report

    Report Number
    2916596-2019-02647
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 28, 2019
    Report Date
    November 19, 2019
    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: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORT OF GI BLEEDING COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES PRIMARILY CONSISTED OF PI EVENTS. THE PUMP¿S SET SPEED REMAINED AT OR ABOVE THE LOW SPEED LIMIT THROUGHOUT THE DURATION OF THE FILES AND THE SYSTEM APPEARED TO HAVE FUNCTIONED AS INTENDED THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6); NO PRODUCT IS AVAILABLE FOR EVALUATION. THE HM3 LVAS IFU LISTS BLEEDING AND RENAL DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS DOCUMENT CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. ADDITIONALLY, THIS IFU EXPLAINS THAT PER DESIGN, THE DEVICE SPEED DROPS TO THE ¿LOW SPEED LIMIT¿ DURING A PI EVENT AND THEN RAMPS UP TO THE FIXED SPEED. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX THAT COULD BE CAUSED BY FLUCTUATIONS IN VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD CHRONIC KIDNEY DISEASE (2.9) AND RENAL DYSFUNCTION ON ADMISSION, LIKELY SECONDARY TO VOLUME DEPLETION. PATIENT IMPROVED TO 1.4 ON THE DAY OF DISCHARGE. NO FURTHER INFORMATION PROVIDED.

    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 7 MONTHS. THE PATIENT REMAINS ONGOING WITH THE DEVICE. 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 ANEMIA/GASTROINTESTINAL BLEED. THERE WERE NUMEROUS PI EVENTS WITH SPEED DROPS NOTED. WAS ONLY ABLE TO INTERROGATE BACK LESS THAN 24 HOURS. THE PHYSICIAN REQUESTED MORE INFORMATION REGARDING HISTORY. A REVIEW OF THE LOG FILE BY TECHNICAL SERVICES SHOWED STABLE PUMP PARAMETERS IN THE LOG FILE WHICH LASTED FROM (B)(6) 2019. A NUMBER OF PI EVENTS WERE CAPTURED. NO REPORTED ALARMS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019. THE PATIENT PRESENTED ON (B)(6) 2019 WITH CHRONIC DARK STOOLS DUE TO CHRONIC ORAL IRON USE BUT NOTED "DARKER" STOOLS FOR DAYS. 1 DAY BEFORE FELT SICK AND DIZZY EVEN DURING REST, SO THE PATIENT WENT TO THE ED. THE PATIENT STATES THAT THE PATIENT WAS TAKING WARFARIN 6.5 MG BUT 1 WEEK AGO INR WAS 3.6 AND WAS TOLD BY CLINIC TO DECREASE THE WARFARIN DOSE TO 6 MG ORALLY 4 TIMES A DAY. PATIENT INR WAS 8.3 ON THE DAY OF ADMISSION(FROM 3.6). HIGHLY CONCERN FOR DRUG-DRUG INTERACTION. ALSO FOUND WITH AKI ON CKD WITH CREA 2.96, BUN 89, AND BUN/CREATININE RATIO 30. PATIENT DENIED FEVER, CHILLS, WATERY STOOLS N/V. NO ABDOMINAL PAIN. ADDITIONAL INFORMATION WAS RECEIVED THAT STATED THE PATIENT DID NOT RECEIVE ANY ENDOSCOPIC PROCEDURES DURING THE ADMISSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019, AT THE TIME OF DISCHARGE THE PATIENT HAD RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS (PRBC'S) ON (B)(6) 2019 AND 2 UNITS OF PRBC'S ON (B)(6) 2019. NO FURTHER TREATMENT WAS PROVIDED. IT WAS STATED THE PATIENT WAS NO LONGER BLEEDING, INR IMPROVED. GI RECOMMENDED CONTINUATION OF PPI, RESUMING WARFARIN AT 3 MG DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492081 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6148768

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R