BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4889607 · Received July 2, 2015

    Report

    Report Number
    2916596-2015-01220
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    May 9, 2015
    Report Date
    June 5, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 42 DAYS. AN AUTOPSY WAS NOT PERFORMED. THE PUMP WAS NOT RETURNED FOR EVALUATION, AS IT WAS NOT EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED, AND AN AUTOPSY WAS NOT PERFORMED. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENTS LEADING UP TO THE PATIENT'S OUTCOME COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE INSTRUCTIONS FOR USE LISTS THROMBOSIS AND HEMOLYSIS AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. ALTHOUGH A SPECIFIC CAUSE FOR THE REPORTED AORTIC VALVE CUSP THROMBUS AND OTHER EVENTS LEADING UP TO THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE HOSPITAL STAFF REPORTEDLY FELT THAT THE PATIENT'S ISSUES WERE NOT DUE TO THE PUMP BUT RATHER DUE TO HER HYPER-COAGULABLE STATE CAUSED BY HER CANCER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. 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 A LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2015 FOR CHEMOTHERAPY INDUCED CARDIOMYOPATHY. THE PATIENT¿S POST-IMPLANT COURSE WAS COMPLICATED WITH AN ST ELEVATION MYOCARDIAL INFARCTION (STEMI) ASSOCIATED WITH AN AORTIC CUSP CLOT THAT MIGRATED INTO THE LEFT MAIN CORONARY ARTERY. AN EMERGENT PERCUTANEOUS THROMBECTOMY WAS PERFORMED. THE PATIENT WAS PLACED ON DUAL ANTIPLATELET THERAPY WITH ASPIRIN AND TICAGRELOR. DESPITE THE DUAL ANTIPLATELET THERAPY AND AN INR OF GREATER THAN 3, THE PATIENT WAS READMITTED ON (B)(6) 2015 FOR EVALUATION OF A NEWLY RE-ACCUMULATED CLOT ON THE AORTIC VALVE CUSP, PRIMARILY THE LEFT CUSP. THE PATIENT HAS A HISTORY OF BREAST CANCER AND WAS STILL RECEIVING ONGOING CHEMOTHERAPY MEDICATIONS. REPORTEDLY, ALTHOUGH THE PATIENT¿S INR HAD BEEN THERAPEUTIC, IT WAS BELIEVED THAT THE RE-ACCUMULATED CLOT MAY HAVE BEEN DUE TO EFFECTS OF THE CANCER AND CHEMOTHERAPY MEDICATIONS. THE PATIENT WAS ADMITTED FOR SERIAL TROPONIN AND LACTATE DEHYDROGENASE LEVELS AND WAS PLACED ON A HEPARIN DRIP. THE PATIENT WAS EXPERIENCING SOME NEW SHORTNESS OF BREATH, AND HER CARDIAC RHYTHM WAS NOTED TO BE A WIDE COMPLEX VENTRICULAR TACHYCARDIA; AN AMIODARONE INFUSION WAS INITIATED, WITH A LIDOCAINE INFUSION ADDED LATER THAT DAY. GIVEN THE RECURRENCE OF THROMBUS WHILE ON DUAL ANTIPLATELET THERAPY, THE INTERVENTIONAL CARDIOLOGY SERVICE DETERMINED A REPEAT PERCUTANEOUS THROMBECTOMY WAS NOT AN OPTION AT THAT TIME. ADDITIONALLY, THE PATIENT¿S PHYSICIANS DETERMINED THAT SURGICAL INTERVENTION WAS ALSO NOT AN OPTION. ON APPROXIMATELY (B)(6) 2015, THE PATIENT BECAME DIAPHORETIC AND NAUSEATED AND RESPONDED SOMEWHAT TO MORPHINE AND ATIVAN. HOWEVER, OVERNIGHT SHE BECAME INCREASINGLY BRADYCARDIC, HYPOTENSIVE, ACIDOTIC AND HYPERKALEMIC. SHE WAS TRANSFERRED TO THE CORONARY CARE UNIT ON THE MORNING OF (B)(6) 2015 AND UNSPECIFIED VASOPRESSORS WERE INITIATED. IT WAS DETERMINED THAT SHE WAS NOT A CANDIDATE FOR DIALYSIS. THE PATIENT¿S FAMILY ELECTED TO BEGIN A DE-ESCALATION OF CARE INCLUDING WEANING PRESSORS AND NO FURTHER INVASIVE LINES OR PROCEDURES AND COMFORT CARE WAS INITIATED. THE PATIENT EXPIRED LATER THAT DAY. THE PRIMARY CAUSE OF DEATH WAS REPORTED AS CHRONIC COMBINED SYSTOLIC AND DIASTOLIC CONGESTIVE HEART FAILURE. SECONDARY DIAGNOSES WERE: ACUTE KIDNEY INJURY, CARDIOGENIC SHOCK, HIGH ANION GAP METABOLIC ACIDOSIS, HYPERKALEMIA, MULTI-ORGAN FAILURE, RIGHT-SIDED HEART FAILURE, THROMBUS OF THE AORTA, UNSTABLE ANGINA PECTORIS, VENTRICULAR TACHYCARDIA, WIDE-COMPLEX TACHYCARDIA. THE VAD COORDINATOR REPORTED THAT SHE ¿WAS NOT INCLINED TO STATE THAT THE LVAD DEVICE WAS FUNCTIONING AS EXPECTED DUE TO THE FACT THAT SHE HAD A LARGE CLOT IN THE AORTIC VALVE CUSP; HOWEVER WE DO NOT FEEL THAT THE PUMP WAS THE CAUSE OF HER ISSUES BUT HER HYPER-COAGULABLE STATE DUE TO HER CANCER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430292 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death