BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14753808 · Received June 21, 2022

    Report

    Report Number
    2916596-2022-11542
    Event Type
    Death
    Date Received
    June 21, 2022
    Date of Event
    April 1, 2021
    Report Date
    July 28, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DATE OF EVENT IS APPROXIMATE. THE DATA WERE COLLECTED AND ANALYZED BETWEEN SEP 2015 AND APR 2021. ARTICLE INFORMATION: BJELIC, M., WOOD, K., VIDULA, H., MCNITT, S., CHEYNE, C., CHASE, K., BERNSTEIN, W., WYROBEK, J., WU, I., ALEXIS, J., GOLDENBERG, I., & GOSEV, I. (2022). COMPARISON OF EARLY AND LATE POSTOPERATIVE OUTCOMES BETWEEN INTERMACS 1/2 VS. 3/4. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, 41(4), S354. HTTPS://DOI.ORG/10.1016/J.HEALUN.2022.01.1445. UNIVERSITY OF ROCHESTER MEDICAL CENTER, ROCHESTER, NY. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 DEVICES AND THE REPORTED PATIENT EXPIRATIONS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RESEARCH ABSTRACT TITLED ¿COMPARISON OF EARLY AND LATE POSTOPERATIVE OUTCOMES BETWEEN INTERMACS 1/2 VS. ¾¿ WAS RECEIVED. THE STUDY SOUGHT TO INVESTIGATE THE CORRELATION OF HIGHER ACUITY INTERMACS PROFILE AND POST-LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION OUTCOMES IN CAREFULLY SELECTED AND OPTIMIZED PATIENTS. A RETROSPECTIVE STUDY OF 234 PATIENTS FROM A SINGLE INSTITUTION THAT WERE IMPLANTED WITH A HEARTMATE (HM) 3 LVAD BETWEEN SEP2015 AND APR2021 WAS CONDUCTED. BASELINE CHARACTERISTICS AND CLINICAL OUTCOMES WERE COMPARED BASED ON PRE-IMPLANTATION INTERMACS PROFILES 1 AND 2 (IP1-2) VS. 3 AND 4 (IP3-4). THE PRIMARY ENDPOINT OF THE STUDY WAS THE COMPOSITE OF STROKE EVENTS AND DEATH FROM TIME OF HM3 IMPLANTATION THROUGH LATE FOLLOW-UP. OF THE 234 PATIENTS IMPLANTED WITH A HM3 DURING THE STUDY PERIOD 115 (49.6%) PRESENTED IN CARDIOGENIC SHOCK (IP1-2), WHILE 118 (50.4%) WERE LESS ACUTE (IP3-4). PATIENTS WITH AN INTERMACS PROFILE OF 1 AND 2 AT THE TIME OF LVAD IMPLANT WERE YOUNGER WITH DE-NOVO HEART FAILURE AND WORSE END-ORGAN FUNCTION. POSTOPERATIVELY, PATIENTS IN THE IP1-2 GROUP EXPERIENCED HIGHER RATES OF EARLY ADVERSE EVENTS INCLUDING SEVERE RIGHT VENTRICULAR FAILURE AND PROLONGED HOSPITAL LENGTH OF STAY. THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE KAPLAN-MEIER ESTIMATOR FOR THE COMPOSITE END-POINT OF DEATH AND STROKE BETWEEN IP GROUPS. THE STUDY CONCLUDED THAT INTERMACS 1 AND 2 PATIENTS IMPLANTED WITH HM3 LVAD WERE YOUNGER, HAD LONGER INTUBATION TIMES, AND LONGER INTENSIVE CARE UNIT (ICU) AND HOSPITAL LENGTHS OF STAY. CLINICAL OUTCOMES WERE SIMILAR BETWEEN THE GROUPS WITH INTERMACS 3 AND 4 PATIENTS SHOWING A TREND TOWARD A LOWER COMPOSITE EVENT RATE OF STROKE AND DEATH. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. THE HEARTMATE 3 LVAS IFU, REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING DEATH THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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. 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 ABSTRACT ¿COMPARISON OF EARLY AND LATE POSTOPERATIVE OUTCOMES BETWEEN INTERMACS 1/2 VS. ¾¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH DEATH. THIS RETROSPECTIVE STUDY EVALUATED 234 HM3 PATIENTS IMPLANTED BETWEEN SEP 2015 TO APR 2021 DURING THEIR STAY POST-IMPLANT. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THEIR PRE-IMPLANTATION INTERMACS PROFILES; 116 PATIENTS HAD INTERMACS 1 OR 2 (IPI-2), AND 118 PATIENTS HAD INTERMACS 3 OR 4 (IPI-4). RESULTS REVEALED STATISTICALLY SIMILAR CLINICAL OUTCOMES, ALTHOUGH THE IPI-4 GROUP HAD A LOWER ADVERSE EVENT AND DEATH RATE. 19 IPI-2 PATIENTS AND 10 IPI-4 PATIENTS PASSED AWAY WHILE IN THE HOSPITAL (P = 0.067). THE STUDY LATER DID A LATER FOLLOW-UP FOR FURTHER OUTCOMES. DURING THIS TIME, 30 IPI-2 AND 19 IPI-4 PATIENTS PASSED AWAY (P = 0.067). RELATED MANUFACTURER'S REPORT CAPTURING SERIOUS INJURIES: 2916596-2022-11541.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162146 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death