BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 14753767 · Received June 21, 2022

    Report

    Report Number
    2916596-2022-11541
    Event Type
    Injury
    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

    DATE OF EVENT IS APPROXIMATE. THE DATA WERE COLLECTED AND ANALYZED BETWEEN SEP2015 AND APR2021. 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 3 DEVICES AND THE REPORTED EVENTS 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, AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS INCLUDING, INFECTION (LOCAL, DRIVELINE, AND PUMP POCKET), BLEEDING, RIGHT HEART FAILURE, STROKE, RENAL DYSFUNCTION, CARDIAC ARRHYTHMIA, AND RESPIRATORY FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS INFECTION AND CARDIAC ARRHYTHMIA AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER "ANTICOAGULATION"), OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INR RANGE FOR PATIENTS USING THE HEARTMATE 3 LVAS, AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿RIGHT HEART FAILURE), STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. SECTION 6 OF THE IFU, UNDER ¿CAUTION!¿, EXPLAINS THAT RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LEFT VENTRICULAR ASSIST SYSTEM DUE TO REDUCED FILLING OF THE PUMP. 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 INFECTION, MAJOR BLEEDING, RIGHT HEART FAILURE, STROKE, RENAL FAILURE REQUIRING DIALYSIS, ARRHYTHMIA AND RESPIRATORY FAILURE. THIS RETROSPECTIVE STUDY EVALUATED 234 HM3 PATIENTS IMPLANTED BETWEEN SEP2015 TO APR2021 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. INFECTION OCCURRED IN 19 IPI-2 PATIENTS AND 11 IPI-4 PATIENTS (P = 0.106). MAJOR BLEEDING OCCURRED IN 13 IPI-2 PATIENTS AND 6 IPI-4 PATIENTS (P = 0.086). RIGHT HEART FAILURE OCCURRED IN 11 IPI-2 PATIENTS AND 3 IPI-4 PATIENTS (P = 0.025). STROKE OCCURRED IN 8 IPI-2 PATIENTS AND 3 IPI-4 PATIENTS (P = 0.116). CARDIAC ARRHYTHMIA OCCURRED IN 11 IPI-2 PATIENTS AND 7 IPI-4 PATIENTS (P = 0.308). RESPIRATORY FAILURE OCCURRED IN 13 IPI-2 PATIENTS AND 9 IPI-4 PATIENTS (P = 0.348). ADDITIONALLY, IPI-2 PATIENTS SPENT AN AVERAGE OF 124.6 HOURS ON MECHANICAL VENTILATION SUPPORT POST-OPERATIVELY, WHILE IPI-4 PATIENTS SPENT AN AVERAGE 34.1 HOURS ON SUPPORT (P < 0.001). IPI-2 PATIENTS ALSO SPENT AN AVERAGE OF 15.1 DAYS IN THE INTENSIVE CARE UNIT (ICU) AND AN AVERAGE OF 31.8 DAYS OVERALL IN THE HOSPITAL POST-OPERATIVELY; IPI-4 PATIENTS SPENT AN AVERAGE OF 7.5 DAYS IN THE ICU AND 20.2 DAYS OVERALL IN THE HOSPITAL POST-OPERATIVELY (P < 0.001 IN BOTH CASES). THE STUDY LATER DID A LATER FOLLOW-UP FOR FURTHER OUTCOMES. DURING THIS TIME, 44 IPI-2 PATIENTS AND 51 IPI-4 PATIENTS DEVELOPED AN INFECTION (P = 0.41). 25 IPI-2 PATIENTS AND 23 IPI-4 PATIENTS EXPERIENCED MAJOR BLEEDING (P = 0.696). 23 IPI-2 AND 16 IPI-4 PATIENTS EXPERIENCED RIGHT HEART FAILURE (P = 0.198). 15 IPI-2 AND 10 IPI-4 PATIENTS EXPERIENCED A STROKE (P = 0.27). RELATED MANUFACTURER'S REPORT REGARDING DEATH AS AN OUTCOME: 2916596-2022-11542.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201508 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H