BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8499335 · Received April 10, 2019

    Report

    Report Number
    2916596-2019-01521
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    October 9, 2018
    Report Date
    May 30, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G4: THE MANUFACTURER¿S AWARE DATE FOR THIS REPORT REFLECTS THE CORRECTED AWARE DATE OF THE INITIAL REPORT. THE MANUFACTURER¿S INVESTIGATION FOR THIS EVENT CLOSED ON 24MAY2019. THIS REPORT IS BEING SUBMITTED LATE AS A PART OF THE CORRECTION REQUIRED FOR A CAPA INVESTIGATING REPEATED LATE SUBMISSIONS OF CLINICAL DATA TO THE PRODUCT PERFORMANCE GROUP BY A SINGLE CLINICAL SAFETY EMPLOYEE. ABBOTT NOTIFIED FDA OF THE PENDING LATE REPORTS RELATED TO THIS ISSUE. THE LATE REPORTS RELATED TO THIS CAPA ARE EXPECTED TO BE SUBMITTED TO FDA BY MAY 31, 2019. SECTION H1: CORRECTION. THE PATIENT'S DEATH WAS REPORTED IN MFR# 2916596-2018-05691. THIS REPORT WILL ADDRESS THE RIGHT HEART FAILURE AND BLEEDING EVENTS FROM THE OCTOBER ADMISSION. SECTION F9: CORRECTION: APPROXIMATE AGE OF DEVICE ¿ 11 DAYS. INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAD, SERIAL NUMBER (B)(4), WAS NOT RETURNED FOR ANALYSIS. THE HEARTMATE 3 LVAS IFU LISTS RIGHT HEART FAILURE AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS DOCUMENT ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES, AND THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HYPOTENSION AND ASSOCIATED LOW PULSATILITY INDEX (PI) EPISODES. HEMOGLOBIN AND HEMATOCRIT (H/H) WERE LOW AND 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS) WERE TRANSFUSED AND IDIOPATHIC VENTRICULAR FIBRILLATION (IVF) WAS ADMINISTERED WITH MARKED IMPROVEMENT IN BOTH BLOOD PRESSURE AND VENTRICULAR ASSIST DEVICE (VAD) PARAMETERS. H/H HAD INCREASED BUT WAS STILL LOW SO THE PATIENT WAS TRANSFUSED 1 UNIT OF PRBCS. AFTER THIS TRANSFUSION HEMOGLOBIN WAS REPORTED TO HAVE INCREASED. H/H TRENDING WAS DOWN ON (B)(6) 2018 AND THE PATIENT WAS TRANSFUSED 2 UNITS OF PRBCS, AFTER WHICH H/H INCREASED. H/H AGAIN DECREASED AND THE PATIENT WAS GIVEN ANOTHER 2 UNITS OF PRBCS, AND H/H AGAIN INCREASED.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 21 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) 2018. IT WAS REPORTED THAT THE PATIENT REQUIRED INOTROPIC THERAPY FOR MORE THAN 1 WEEK POST LVAD IMPLANT. ON (B)(6) 2018, THE PATIENT WAS TAKEN OFF MILRINONE. ON (B)(6) 2018, PATIENT WAS RESTARTED ON MILRINONE, DUE TO THE FACT THAT LEFT/RIGHT HEART CATHETERIZATION SHOWED EVIDENCE OF RIGHT VENTRICULAR FAILURE. PATIENT WAS DISCHARGED ON (B)(6) 2018 AND WAS GIVEN A DOSAGE OF DOBUTAMINE. PATIENT TOOK MEDICATION UNTIL HE EXPIRED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292770 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524 6509047

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| H| R