BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8220345 · Received January 4, 2019

    Report

    Report Number
    2916596-2018-05886
    Event Type
    Death
    Date Received
    January 4, 2019
    Date of Event
    December 14, 2018
    Report Date
    February 4, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OF DEVICE: 2 DAYS. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT THE PATIENT, IMPLANTED ON (B)(6) 2018, RETURNED TO THE O.R ON (B)(6) 2018 FOR RE-EXPLORATION DUE TO BLEEDING AND TAMPONADE. POD 1 (POST-OPERATIVE DAY 1) LABS REPORTEDLY SHOWED VARIOUS INCREASED CLINICAL PARAMETERS, INCLUDING INCREASED CREATINE (CR) LEVELS, AND LACTATE DEHYDROGENASE (LDH) GREATER THAN 12,000 U/L. THE PATIENT WAS STARTED ON CONTINUOUS VENOVENOUS HEMODIALYSIS (CVVHD). THE PATIENT RETURNED TO THE OR AGAIN ON (B)(6) 2018 DUE TO TAMPONADE. POD 2 LABS SHOWED NO IMPROVEMENT, AND THE PATIENT EXHIBITED AN ONGOING PROGRESSION OF MULTI-SYSTEM ORGAN FAILURE (MSOF), GOING INTO REFRACTORY SHOCK AND SUBSEQUENTLY ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). DURING AN EXAM THAT SAME DAY, THE PATIENT WAS EXPERIENCING ABDOMINAL PAIN, DISTENTION, FLANK ECCHYMOSIS, AND THERE WAS CONCERN FOR BOWEL ISCHEMIA SECONDARY TO SHOCK. DESPITE CONTINUED MAXIMAL MEDICAL MANAGEMENT, THE PATIENT CONTINUED TO DETERIORATE WITH ABRUPT DROP IN LVAD FLOWS AND SUBSEQUENT ARREST. ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS INITIATED, BUT STOPPED AFTER TALKING TO THE PATIENT¿S SPOUSE. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2018 DUE TO HEPATIC FAILURE, ISCHEMIC CARDIOMYOPATHY, VENTRICULAR ARRHYTHMIA, AND CARDIOGENIC SHOCK. THE CENTER REPORTED THERE BEING NO REPORT IF PUMP WAS EXPLANTED. TO DATE, NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION WILL BE RE-ASSESSED IF ANY PRODUCT IS RECEIVED. THE HEARTMATE 3 LVAS IFU, DOCUMENT #10006135, REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT HEMOLYSIS, CARDIAC ARRHYTHMIA, BLEEDING, RENAL FAILURE, RESPIRATORY FAILURE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. PATIENT WAS READMITTED DUE TO BLEEDING. PATIENT'S LAB REPORT RESULT INCLUDE: CREATININE (CR) 2.6, BILIRUBIN 3.6 U/L, ALANINE TRANSAMINASE (ALT) GREATER THAN 5000, ASPARTATE TRANSAMINASE (AST) GREATER THAN 10000 U/L, ALKALINE PHOSPHATASE LEVEL (ALKPHOS) 295 U/L, LACTATE 23 U/L, LACTATE DEHYDROGENASE (LDH) WAS HIGHER THAN 12000 U/L. PATIENT WAS STARTED ON CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD) TO CLEAR LACTATE, INR WAS 4.5. PATIENT RETURNED TO OPERATING ROOM (OR) ON (B)(6) 2018 DUE TO TAMPONADE. NO IMPROVEMENT IN LAB RESULTS WERE OBSERVED. PATIENT'S MULTISYSTEM ORGAN FAILURE (MSOF) PROGRESSED IN REFRACTORY SHOCK LEADING TO ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). ON (B)(6) 2018 PATIENT HAD ABDOMINAL PAIN, DISTENTION, FLANK ECCHYMOSIS, CONCERNING FOR BOWEL ISCHEMIA SECONDARY TO SHOCK. DESPITE CONTINUED MAXIMAL MEDICAL MANAGEMENT, PATIENT CONTINUED TO DETERIORATE WITH ABRUPT DROP IN LVAD FLOWS AND SUBSEQUENT ARREST. PATIENT EXPIRED ON (B)(6) 2018 DUE TO HEPATIC FAILURE, ISCHEMIC CARDIOMYOPATHY, VENTRICULAR ARRHYTHMIA, AND CARDIOGENIC SHOCK. AUTOPSY WAS REQUESTED BUT NO REPORT ON PUMP EXPLANT WAS RECEIVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9276 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 6653087 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| H| L