BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21528153 · Received March 5, 2025

    Report

    Report Number
    2916596-2025-01309
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    March 1, 2021
    Report Date
    May 23, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011712
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. ARSLAN, A., ÖZKAYA, Ö. G., AYTEMIZ, F., ALTAY, H., ÖZCAN, E. E., KÜÇÜKAKSU, D. S., BAKUY, V., KOZAN, Ö., & PEHLIVANOGLU, S. (2024). ORAL AMIODARONE AND PROPRANOLOL IN MAINTENANCE THERAPY OF POSTIMPLANTATION TACHYCARDIA: AN OBSERVATIONAL STUDY. MEDICINE, 103(28), E38839. HTTPS://DOI.ORG/10.1097/MD.0000000000038839. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED LOW FLOW ALARMS WERE UNABLE TO BE CONFIRMED, AS NO LOG FILES WERE SUBMITTED FOR ANALYSIS. A SPECIFIC CAUSE FOR THESE EVENTS WERE UNABLE TO BE DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), WITH NO FURTHER ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU, REV. G AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. G ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1 OF THE IFU ALSO PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING PUMP FLOW. THIS SECTION ALSO EXPLAINS THAT PUMP FLOW IS A CALCULATED VALUE THAT IS ESTIMATED BASED ON PUMP POWER. SECTION 4 "SYSTEM MONITOR" PROVIDES INFORMATION ABOUT THE PUMP FLOW DISPLAY AND THE LOW FLOW HAZARD ALARM. THIS SECTION STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN THE ESTIMATED PUMP FLOW IS LESS THAN 2.5 LPM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS CARDIAC ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. FURTHERMORE, SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", AND SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. SECTION 8 OF THE PATIENT HANDBOOK, ¿HANDLING EMERGENCIES¿, ALSO PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE, "ORAL AMIODARONE AND PROPRANOLOL IN MAINTENANCE THERAPY OF POSTIMPLANTATION TACHYCARDIA AN OBSERVATIONAL STUDY" THAT A 67-YEAR-OLD MAN WITH CORONARY ARTERY DISEASE (CAD) PERIPHERAL ARTERIAL DISEASE, AND ISCHEMIC HEART FAILURE WAS IMPLANTED WITH A HEARTMATE 3 AND WAS EVALUATED FOR THE CLINICAL EFFICACY OF ORALLY ADMINISTERED AMIODARONE AND PROPRANOLOL. SUPRAVENTRICULAR TACHYCARDIA (SVT) WAS OBSERVED AFTER 96 HOURS. THE DUAL CHAMBER IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) DID NOT APPLY SHOCK, AS IT WAS TRIGGERED TO WHEN THE HEART RATE EXCEEDED 168 BEATS PER MINUTE. WHILE THE PATIENT¿S HEMODYNAMICS WAS CLOSELY MONITORED, A SINUS RHYTHM WAS NOT ACHIEVED WITH AN INTRAVENOUS (IV) BOLUS OF 300 MG AMIODARONE. THUS, 50 MG IV LIDOCAINE AND 40 MG/H IV AMIODARONE WERE INFUSED, ALONG WITH 2 MG IV MAGNESIUM. HOWEVER, VENTRICULAR TACHYCARDIA (VT) CONTINUED, AND AN (ICD) CONTROLLER DEVICE WAS REQUESTED. WHEN THE PATIENT¿S HEMODYNAMICS DETERIORATED BEFORE THE DEVICE WAS SUPPLIED, THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) PUMP FLOW RATE DECREASED FROM 3.5 TO 2.4 LITERS/MINUTE. THUS, IV FLUID REPLACEMENT WAS INITIATED, AND THE PATIENT WAS DEFIBRILLATED (150 JOULES) UNDER SEDATION USING AN EXTERNAL DEFIBRILLATOR WITH ANTERIOR¿POSTERIOR PATCHES. THEREAFTER, A SINUS RHYTHM AND IMPROVED HEMODYNAMICS WERE OBSERVED. FOR MAINTENANCE, 120 MG/DAY ORAL PROPRANOLOL WAS ADMINISTERED, AND AMIODARONE WAS REPLACED WITH 400 MG/DAY MEXILETINE OWING TO THE DEVELOPMENT OF AMIODARONE-INDUCED HYPERTHYROIDISM. THE PATIENT WAS DISCHARGED ON DAY 9 AFTER THE PROCEDURE. AT THE 15-MONTH FOLLOW-UP, NO SVT AND NON-SUSTAINED VT WERE NOTED.

    Description of Event or Problem · 0

    THIS EVENT WAS NEVER ADDRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449145 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 6770011 00813024011712

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| H