BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21501412 · Received March 2, 2025

    Report

    Report Number
    2916596-2025-01464
    Event Type
    Malfunction
    Date Received
    March 2, 2025
    Date of Event
    January 6, 2023
    Report Date
    March 25, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5:SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS: 01JUN2023 AS PATIENTS WERE IMPLANTED FROM MAR2015 TO JUN2023. DEPARTMENT OF CARDIAC, THORACIC, VASCULAR SCIENCES AND PUBLIC HEALTH, UNIVERSITY OF PADOVA, PADUA, ITALY, DEPARTMENT OF CLINICAL ELECTROPHYSIOLOGY & CARDIAC PACING, CENTRO CARDIOLOGICO MONZINO, IRCCS, MILAN, ITALY, DEPARTMENT OF SYSTEMS MEDICINE, UNIVERSITY OF ROME TOR VERGATA, ROME, ITALY, CARDIOLOGY UNIT, LUIGI SACCO UNIVERSITY HOSPITAL, MILAN, ITALY, CARDIOLOGY UNIT, IRCCS, DEPARTMENT OF EXPERIMENTAL, DIAGNOSTIC AND SPECIALTY MEDICINE, SANT'ORSOLA HOSPITAL, UNIVERSITY OF BOLOGNA, BOLOGNA, ITALY, ARRHYTHMOLOGY AND ELECTROPHYSIOLOGY UNIT, SAN RAFFAELE HOSPITAL, IRCCS, MILAN, ITALY,CARDIOLOGY UNIT, UNIVERSITY MEDICAL CENTRE MANNHEIM, MANNHEIM, GERMANY, DEPARTMENT OF CARDIOLOGY AND ANGIOLOGY, FACULTY OF MEDICINE, HEART, CENTER FREIBURG UNIVERSITY, UNIVERSITY OF FREIBURG, GERMANY,CARDIOLOGY UNIT, FONDAZIONE IRCCS SAN GERARDO DEI TINTORI, MONZA, ITALY, DEPARTMENT OF RHYTHMOLOGY, UNIVERSITY HEART CENTER LUBECK, LUBECK, GERMANY, DEPARTMENT OF BIOMEDICAL SURGICAL AND DENTAL SCIENCES, UNIVERSITY OF MILAN, MILAN, ITALY, MONTEFIORE-EINSTEIN CENTER FOR HEART AND VASCULAR CARE, MONTEFIORE MEDICAL CENTER, ALBERT EINSTEIN COLLEGE OF MEDICINE AT MONTEFIORE HEALTH SYSTEM, BRONX, NY, USA, DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, BALTIMORE, USA. MIGLIORE, F., SCHIAVONE, M., PITTORRU, R., FORLEO, G. B., DE LAZZARI, M., MITACCHIONE, G., BIFFI, M., GULLETTA, S., KUSCHYK, J., DALL¿AGLIO, P. B., ROVARIS, G., TILZ, R., MASTRO, F. R., ILICETO, S., TONDO, C., DI BIASE, L., GASPERETTI, A., TARZIA, V., & GEROSA, G. (2024). LEFT VENTRICULAR ASSIST DEVICE IN THE PRESENCE OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: DATA FROM A MULTICENTER EXPERIENCE. INTERNATIONAL JOURNAL OF CARDIOLOGY, 400, 131807. HTTPS://DOI.ORG/10.1016/J.IJCARD.2024.131807. NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 DEVICE AND THE REPORTED ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ARTICLE CONCLUDED THAT CONCOMITANT USE OF LVAD AND S-ICD WAS FEASIBLE IN MOST PATIENTS, HOWEVER, THERE IS A POTENTIAL RISK OF EMI OVERSENSING, INAPPROPRIATE SHOCKS, AND UNDERSENSING. THE HEARTMATE 3 DEVICE SERIAL NUMBER, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, IS NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. G IS CURRENTLY AVAILABLE. THE IFU WARNS THAT THE HEARTMATE 3 PUMP MAY CAUSE INTERFERENCE WITH IMPLANTABLE CARDIAC DEFIBRILLATORS (ICDS). IF ELECTROMAGNETIC INTERFERENCE OCCURS, IT MAY LEAD TO INAPPROPRIATE ICD THERAPY. THE OCCURRENCE OF ELECTROMAGNETIC INTERFERENCE WITH ICD SENSING MAY REQUIRE ADJUSTMENT OF DEVICE SENSITIVITY AND/OR REPOSITIONING THE LEAD." THE IFU ADDITIONALLY STATES THAT PRIOR TO IMPLANTING AN IMPLANTABLE CARDIAC DEFIBRILLATOR OR IMPLANTABLE PACEMAKER (IPM) IN A HEARTMATE 3 PATIENT, THE DEVICE TO BE IMPLANTED SHOULD BE PLACED IN CLOSE PROXIMITY TO THE PUMP (APPROXIMATELY 10 CM) AND THE TELEMETRY VERIFIED. IF A PATIENT RECEIVES A HEARTMATE 3 AND HAS A PREVIOUSLY IMPLANTED DEVICE THAT IS FOUND TO BE SUSCEPTIBLE TO ELECTROMAGNETIC INTERFERENCE WHICH COULD AFFECT PROGRAMMING, ABBOTT RECOMMENDS REPLACING THE ICD OR IMPLANTABLE PACEMAKER (IPM) DEVICE WITH ONE THAT IS NOT PRONE TO PROGRAMMING INTERFERENCE. THE IFU STATES THAT THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM CAN GENERATE, USE, AND RADIATE RADIO FREQUENCY ENERGY AND, IF NOT INSTALLED AND USED IN ACCORDANCE WITH THE INSTRUCTIONS, MAY CAUSE HARMFUL INTERFERENCE TO OTHER DEVICES IN THE VICINITY. HOWEVER, THERE IS NO GUARANTEE THAT INTERFERENCE WILL NOT OCCUR IN A PARTICULAR INSTALLATION. IF THIS EQUIPMENT DOES CAUSE HARMFUL INTERFERENCE TO OTHER DEVICES, THE USER IS ENCOURAGED TO TRY TO CORRECT THE INTERFERENCE BY REORIENTING OR RELOCATING THE EQUIPMENT, INCREASING THE SEPARATION BETWEEN THE EQUIPMENT, OR CONSULTING ABBOTT FOR ASSISTANCE. THE HEARTMATE 3 DESIGN MEETS ALL ELECTROMAGNETIC (EMC) REQUIREMENTS AS OUTLINED IN THIS SECTION. 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 ARTICLE ¿LEFT VENTRICULAR ASSIST DEVICE IN THE PRESENCE OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: DATA FROM A MULTICENTER EXPERIENCE¿ THAT THE PATIENT EXPERIENCED INAPPROPRIATE SHOCKS FROM THEIR SUBCUTANEOUS-IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING. THEY EXPERIENCED PRIMARY AND SECONDARY EMI ON THE PRIMARY PROGRAMMED SENSING VECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164696 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male