BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9647987 · Received January 30, 2020

    Report

    Report Number
    2916596-2020-00177
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    October 13, 2019
    Report Date
    April 24, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    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 · 0

    ADDITIONAL INFORMATION: SECTION B5.

    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 INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION 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. INFECTION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH DIABETES, CORONARY ARTERY DISEASE, CHRONIC HEART FAILURE STATUS POST LVAD ON (B)(6) 2018, PRESENTED WITH FEVER AND ONE WEEK OF MID ABDOMINAL PAIN. TENDER FIRM MASS PALPATED IN RIGHT MID ABDOMEN. POSITIVE FOR GRAM POSITIVE RODS, SERRATIA MARCESCENS AND CORYNEBACTERIUM STRIATUM. METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS OR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS WERE NOT REPORTED ON THE CULTURE. PATIENT EMPIRICALLY RECEIVED VANCOMYCIN / ZOSYN. STARTED VANOMCYIN ON 1.25 G Q 24 HOURS, STARTED CEFEPIME 1G Q 12 HOURS. INFECTION WAS RESOLVED. PLAN OF CARE WAS TO CONTINUE LVAD CLINIC AND REGULAR FOLLOW UP WITH HEART FAILURE TEAM. PER EMR OF THE PATIENT; THE SUBJECT HAD SLOW OOZING FROM THE DRIVELINE ON (B)(6) 2019 THAT WAS NOT CLINICALLY SIGNIFICANT. NO FURTHER INFORMATION WAS 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 GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). NO FURTHER 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 WAS ADMITTED AFTER A THREE TO FOUR DAY HISTORY OF ABDOMINAL PAIN. THERE WAS NO NAUSEA, VOMITING, DIARRHEA, OR CONSTIPATION. PATIENT WAS POSITIVE FOR FEVER. PATIENT'S BLOOD CULTURES HAVE BEEN NEGATIVE TO DATE. THE ABDOMINAL CT REVEALED INFLAMMATORY CHANGES AROUND THE DRIVELINE CONSISTENT WITH INFECTION. DRAINAGE FROM THE DRIVELINE SITE WAS CULTURED AND GROWING CORYNEBACTERIUM. THE PATIENT HAD BEEN RECEIVING IV CEFEPIME AND IV VANCOMYCIN. THE PATIENT HAS POST CARDIAC INJURY SYNDROME (PCIS) STATUS POST HM3 LVAD AND A POST-VAD COURSE COMPLICATED OOZING FROM DRIVELINE AND PRESENTED AS TRANSFER FROM ABDOMINAL PAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113205 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R