BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 10140744 · Received June 10, 2020

    Report

    Report Number
    2916596-2020-02928
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 12, 2020
    Report Date
    September 14, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. NO ALARMS OR FUNCTIONAL ISSUES WITH THE LVAS WERE REPORTED IN ASSOCIATION WITH THE EVENT. THE PATIENT REMAINS ONGOING ON (B)(6) AND NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING, CARDIAC ARRHYTHMIA, RIGHT HEART FAILURE, RESPIRATORY FAILURE, AND RENAL DYSFUNCTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. ARRHYTHMIA AND THROMBOEMBOLISM ARE ALSO INCLUDED IN THE LIST OF POTENTIAL LATE POST-IMPLANT COMPLICATIONS WITHIN THE IFU. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION B5 AND H6 (PATIENT CODES): ADDITIONAL INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT RETURNED TO CLINIC (B)(6) 2020 WITH NO COMPLAINTS OF BLEEDING AND HEMOGLOBIN (HGB) 9.2 G/DL AND HEMATOCRIT 31 % (HCT). START DATE WAS (B)(6) 2020 AND RESOLVED (B)(6) 2020. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6)2020 WITH 1 TO 2 DAYS OF DARK COLORED STOOLS AND FEELING FATIGUED AND DYSPNEIC. HEMOGLOBIN 6.9 ON ADMISSION. GASTROINTESTINAL (GI)CONSULTED (B)(6)2020 AND DECIDED AGAINST ENDOSCOPY DUE TO HIGH RISK AND NO FRANK BLEEDING. ADMITTED TO CTICU WITH PREDOMINANT RV FAILURE (B)(6)2020, AFTER PRESENTING TO ED WITH FATIGUE, GIB, AND AKI. STARTED ON DOPAMINE, VASOPRESSIN AND LASIX INFUSIONS. TTE REVEALED DILATED RV WITH MODERATE CONTRACTILE DYSFUNCTION, MODERATE TR AND AN UNDERFILLED LV. IT WAS REPORTED THAT THE PATIENT DEVELOPED SIGNIFICANT EPISTAXIS ON (B)(6)2020 WHILE ADMITTED TO THE CARDIOTHORACIC INTENSIVE CARE UNIT (CTICU), REQUIRING EARS, NOSE AND THROAT (ENT) CONSULT AND RHINO ROCKET PLACEMENT. RHINO ROCKET DEFLATED ON (B)(6)2020 AND REMOVED ON (B)(6)2020 WITH MILD BLEEDING. THE PATIENT RECEIVED A TOTAL 8 UNITS OF FRESH FROZEN PLASMA (FFP) AND 10 UNITS PACKED RED BLOOD CELLS (PRBCS). WHILE ADMITTED, HYPERCARBIA ON (B)(6)2020 REPORTED. THE PATIENT WAS PLACED ON BIPAP ON ED WITH C02 OF 92. THE PATIENT USES BIPAP AT HOME AND HAS BASELINE CO2 IN 70S. ON ADMISSION THE PATIENT HAD SIGNIFICANT RESPIRATORY ACIDOSIS (ABG: 7.16/92/148/33), HOWEVER IMPROVED WITH BIPAP AND DID NOT REQUIRE INTUBATION THIS HOSPITALIZATION. INFECTIOUS WORK-UP WAS NEGATIVE. TREATED WITH 3-DAY STEROID. WORSENING RESPIRATORY STATUS LIKELY RELATED TO WORSENING RESIDUAL VOLUME RIGHT VENTRICLE FAILURE IN THE SETTING OF SIGNIFICANT CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). AFTER GOALS OF CARE DISCUSSION, THE PATIENT MADE A DO-NOT-RESUSCITATE ORDER (DNR) AND DO-NOT-INTUBATE (DNI) ORDER. THE PATIENT WAS TRANSFERRED FROM THE ICU TO STEP DOWN FLOOR ON (B)(6)2020. SUPPLEMENTAL O2 WEANED TO NASAL CANNULA AND ULTIMATELY OFF. ADMITTED TO CTICU WITH PREDOMINANT RIGHT VENTRICULAR FAILURE ON (B)(6)2020. THE PATIENT WAS ALSO STARTED ON DOPAMINE, VASOPRESSIN AND LASIX INFUSIONS. TRANSTHORACIC ECHOCARDIOGRAM (TTE) REVEALED DILATED RV WITH MODERATE CONTRACTILE DYSFUNCTION, MODERATE TRICUSPID INSUFFICIENCY (TI) AND AN UNDERFILLED LV. PULMONARY ARTERY (PA) CATHETER SHOWED PAP 38/22, CENTRAL VENOUS PRESSURE (CVP) 22, CI 2.7. MILRINONE AND NOREPINEPHRINE INFUSIONS ADDED. MILRINONE OFF (B)(6)2020. NOREPINEPHRINE OFF (B)(6)2020. VASOPRESSIN AND LASIX OFF (B)(6)2020. DOPAMINE OFF (B)(6)2020. THE PATIENT¿S HEMOGLOBIN (HGB) STABLE AT 8.8 G/DL AT DISCHARGE. TREATMENT INCLUDED PROLONGED HOSPITALIZATION CHANGES TO MEDICATION; INOTROPES AND BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED HOME (B)(6)2020 WITH HEMOGLOBIN 8.8 G/DL AND HOME PALLIATIVE CARE SERVICES.

    Additional Manufacturer Narrative · 1

    THE REFERENCED OF THE PATIENT'S PREVIOUS INFECTION WAS REPORTED UNDER MFR# 2916596-2020-00926 THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# G140113. 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). THE PATIENT REMAINS ONGOING WITH THE LVAD 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

    IT WAS REPORTED THAT OVER THE PAST FOUR DAYS THE PATIENT HAS HAD WORSENING DYSPNEA ON EXERTION. ALSO REPORTS WORSENING OF CHRONIC ORTHOPNEA, AND ABDOMINAL DISTENTION ALONG WITH ABOUT A 2 LB WEIGHT GAIN OVER THE PAST FEW DAYS. THE PATIENT¿S LOWER EXTREMITY EDEMA IS STABLE. UNCLEAR ETIOLOGY OF CURRENT DECOMPENSATION. NO EVIDENCE OF LVAD DYSFUNCTION. THE PATIENT WAS DIURESED WITH INTRAVENOUS (IV) LASIX INFUSION AND INTERMITTENT METOLAZONE AND DIURIL. ALSO ADDED DOPAMINE TO AUGMENT DIURESIS ALTHOUGH HAD TO DISCONTINUE DUE TO ATRIAL FIBRILLATION (AF) RATE OR RESPONSE (RVR) WITH VENTRICULAR RATES 120S-140S. MIDODRINE WAS UTILIZED INSTEAD AND CONTINUED AT DISCHARGE. THE PATIENT TRANSITIONED TO TORSEMIDE. AND UNDERWENT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WHICH SHOWED LEFT ATRIAL APPENDAGE (LAA) MASS, NON-MOBILE; THOUGHT TO BE MURAL THROMBUS. GIVEN THE PATIENT HAS A HISTORY OF INFECTION REQUIRING REMOVAL OF PRIOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), THE PATIENT DEEMED TO BE POOR CANDIDATE FOR ATRIOVENTRICULAR JUNCTION (AVJ) ABLATION AND PACER. IT WAS FELT BENEFITS OF RATE CONTROL WITH AMIODARONE FAR EXCEEDED THE RISKS OF STROKE FROM POSSIBLE CHEMICAL CARDIOVERSION. THE RATE CONTROL IMPROVED SUBSTANTIALLY FROM 130S TO 70S WITH 5G AMIODARONE LOAD AND TRANSITIONED TO MAINTENANCE AMIODARONE. ON (B)(6) 2020, THE PATIENT'S HEMOGLOBIN (HGB) DROPPED TO 7.7 G/DL AND GUIAC POSITIVE STOOL CONCERNING FOR GASTROINTESTINAL BLEEDING (GI) IN THE SETTING OF HEPARIN BRIDGE. THE PATIENT HAD PREVIOUSLY BEEN TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS) FOR ANEMIA. A 3RD UNIT ORDERED AND TRANSFUSED BUT WAS STOPPED AFTER APPROXIMATELY ONE HOUR DUE TO TRANSFUSION REACTION. AT THAT TIME THE PATIENT¿S MONITOR SIGNALED OXYGEN DESATURATION INTO THE MID 80'S AND PLACED ON OXYGEN AT 1 LPM AND OXYGEN SATURATION QUICKLY CLIMBED TO 98%. THE PATIENT WAS OBSERVED TO HAVE SLIGHTLY MORE RAPID BREATHING AND FLUSHED FACE AND COMPLAINED OF FEELING HOT. BLOOD WAS SENT TO TRANSFUSION SERVICES AND URINE WAS SENT FOR ANALYSIS. THE PATIENT CONDITION RAPIDLY IMPROVED WITHIN MINUTES OF STOPPING THE TRANSFUSION. THE PATIENT¿S LACTATE DEHYDROGENASE (LDH) AND HAPTOGLOBIN WERE NORMAL. NO MELENA, HEMATOCHEZIA, HEMATEMESIS, EPISTAXIS OBSERVED. THE PATIENT¿S HEPARIN BRIDGE WAS STOPPED AND HGB IMPROVED TO 8.5 G/DL. THE PATIENT DID NOT UNDERGO FORMAL GI EVALUATION. THE REPORTED EVENT STARTED ON (B)(6) 2020 AND RESOLVED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603954 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 6500883

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R