BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14546812 · Received May 31, 2022

    Report

    Report Number
    2916596-2022-11243
    Event Type
    Death
    Date Received
    May 31, 2022
    Date of Event
    December 31, 2021
    Report Date
    May 31, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE (DECEMBER 2021) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. DEVICE WAS IMPLANTED AT TIME OF EVENT. ARTICLE INFORMATION: EYAL NOF ET AL. EUROPACE (2022) 24, 598¿605. HTTP://DX.DOI.ORG/10.1093/ EUROPACE/EUA(B)(4). (B)(6) CENTER, (B)(6) MEDICAL CENTER, (B)(4). MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 DEVICES AND THE REPORTED PATIENT EXPIRATIONS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AND OTHER SPECIFIC CASE/PATIENT INFORMATION IS NOT AVAILABLE AND WAS NOT REQUESTED. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) (REV. G) IS CURRENTLY AVAILABLE. DEATH IS LISTED IN THE HEARTMATE 3 LVAS IFU AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE DATE OF THE EVENT HAS BEEN ENTERED AS THE PUBLISHED DATE AS THE DATE OF DATA COLLECTION WAS NOT PROVIDED. IT WAS REPORTED THROUGH THE RESEARCH ARTICLE TITLED ¿HEARTMATE 3: NEW CHALLENGES IN VENTRICULAR TACHYCARDIA ABLATION¿ IDENTIFYING THAT HEARTMATE (HM) 3 MAY BE RELATED TO CARDIAC ARRHYTHMIA. THIS WAS A RETROSPECTIVE STUDY, WHICH EVALUATED A TOTAL OF 19 HM3 PATIENTS THAT HAD UNDERGONE VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) ABLATION. DEMOGRAPHIC DATA SHOWED THAT 42% HAD HISTORY OF ATRIAL FIBRILLATION AND 89% PATIENTS HAD A HISTORY OF VT PRIOR TO LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. THE ELIMINATION OF THE CLINICAL VT WAS ACHIEVED IN 15 CASES (83%). POST-ABLATION PROGRAMMED VENTRICULAR STIMULATION (PVS) WAS PERFORMED IN ALL CASES AND THE NON-INDUCIBILITY OF ANY VT WAS REACHED IN 10 (56%). SUCCESS RATES WERE SIMILAR IN PATIENTS WITH ISCHEMIC AND NON-ISCHEMIC CARDIOMYOPATHY. A SINGLE PATIENT DEVELOPED COMPLETE ATRIOVENTRICULAR BLOCK AND SUSTAINED A STROKE COMPLICATED BY THE HEMORRHAGIC TRANSFORMATION. TEN PATIENTS (55%) WERE DISCHARGED WITH ANTIARRHYTHMIC TREATMENT. OVER A MEDIAN FOLLOW-UP OF 492 DAYS, 6 (33%) PATIENTS PRESENTED WITH RECURRENT VTS AND UNDERWENT A REPEAT VT ABLATION. TWO PATIENTS UNDERWENT HEART TRANSPLANTATION, ONE OF WHOM DIED FROM SURGICAL COMPLICATIONS WITHIN A DAY. ANOTHER PATIENT DIED MORE THAN A YEAR AFTER THE PROCEDURE. SEVERE ELECTROMAGNETIC INTERFERENCE WAS ALSO PRESENTED ON THE SURFACE ELECTROCARDIOGRAM. RELATED ADVERSE EVENT MFR #: 2916596-2022-11242 RELATED MALFUNCTION MFR #: 2916596-2022-11245.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679592 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death