BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21493537 · Received February 28, 2025

    Report

    Report Number
    2916596-2025-01468
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    January 6, 2023
    Report Date
    March 27, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    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

    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. 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

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM AND THE REPORTED ELECTROMAGNETIC INTERFERENCE (EMI) COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE ARTICLE DESCRIBED ONE PATIENT WHO EXPERIENCED EMI. THE REASON FOR THE IS WAS P-, T-WAVE OVERSENSING. THE SENSING VECTOR HAD LOW R-WAVE AMPLITUDE ON THE ALTERNATE VECTOR. MANAGEMENT OF THE EMI WAS INELIGIBLE FOR S-ICD. THE STUDY CONCLUDED THAT ALTHOUGH ASSOCIATED USE OF LVAD AND S-ICD IS FEASIBLE IN MOST PATIENTS, THERE IS THE POTENTIAL RISK OF EMI OVERSENSING, IS AND UNDERSENSING IN THE POST-OPERATIVE. THEREFORE, SCREENING FOR EMI SHOULD BE PERFORMED IN ALL SENSING VECTORS AFTER LVAD IMPLANTATION. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. G, ARE CURRENTLY AVAILABLE. THE IFU WARNS THE USER 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 ALSO WARNS THAT IF A PATIENT RECEIVES A HEARTMATE 3 PUMP AND HAS A PREVIOUSLY IMPLANTED DEVICE THAT IS FOUND TO BE SUSCEPTIBLE TO ELECTROMAGNETIC INTERFERENCE WHICH COULD AFFECT PROGRAMMING, ABBOTT RECOMMENDS REPLACING THE ICD DEVICE WITH ONE THAT IS NOT PRONE TO PROGRAMMING INTERFERENCE. SECTION C, "SAFETY TESTING AND CLASSIFICATION", 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. EXPERIENCE INDICATES THAT CERTAIN MODELS OF ICDS MAY, IN SOME CASES, NOT BE ABLE TO ESTABLISH TELEMETRY AND BE REPROGRAMMED DUE TO ELECTROMAGNETIC INTERFERENCE WHEN USED WITH THE HEARTMATE 3 LVAS. IN SUCH CASES THE ICDS HAVE CONTINUED TO FUNCTION PROPERLY AND ONLY THEIR ABILITY TO COMMUNICATE WITH THE PROGRAMMER WAS AFFECTED. THE HEARTMATE 3 LVAS COMPLIES WITH APPLICABLE ELECTROMAGNETIC COMPATIBILITY STANDARDS AND IS NOT INFLUENCED BY SUCH DEVICES. THE ABBOTT WEBSITE INCLUDES A LIST OF ICD MAKE/MODELS WHERE DIFFICULTY OR INABILITY TO COMMUNICATE WITH THE ICD PROGRAMMER HAS BEEN REPORTED DURING HM3 LVAS USE. 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 (IS) FROM THEIR SUBCUTANEOUS-IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING. THEY EXPERIENCED PRIMARY AND SECONDARY EMI ON THE ALTERNATE SENSING VECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122242 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male