BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20689137 · Received November 14, 2024

    Report

    Report Number
    2916596-2024-07567
    Event Type
    Death
    Date Received
    November 14, 2024
    Date of Event
    March 1, 2021
    Report Date
    January 14, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT INFORMATION IS UNKNOWN. D4: DEVICE INFORMATION IS UNKNOWN. REFERENCE: MICHAEL KIRSCHNER ET AL., THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY. 2023/12/27. HTTP://DX.DOI.ORG/10.1016/J.JTCVS.2023.12.019.

    Additional Manufacturer Narrative · 0

    SECTION D1: BRAND NAME CORRECTED SECTION D4: MODEL, CATALOG, AND UDI NUMBERS CORRECTED SECTION E1: CUSTOMER SITE CORRECTED SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ABSTRACT. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS 01MAR2021 SINCE THE PATIENTS WERE IMPLANTED BETWEEN JANUARY 2014 AND MARCH 2021. AUTHOR CITATION: MICHAEL KIRSCHNER ET AL. COMPARING 3-YEAR SURVIVAL AND READMISSIONS BETWEEN HEARTMATE 3 AND HEART TRANSPLANT AS PRIMARY TREATMENT FOR ADVANCED HEART FAILURE. J THORAC CARDIOVASC SURG. 2025 JAN;169(1):148-159.E3. DOI: 10.1016/J.JTCVS.2023.12.019. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WAS NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, ¿INTRODUCTION¿, ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING DEATH. 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 ARTICLE TITLED ¿COMPARING 3-YEAR SURVIVAL AND READMISSIONS BETWEEN HEARTMATE 3 AND HEART TRANSPLANT AS PRIMARY TREATMENT FOR ADVANCED HEART FAILURE¿ IDENTIFYING THAT HM3 MAY BE RELATED TO DEATH, HIGHER RATE OF READMISSIONS DUE INFECTION, THROMBUS, LVAD MALFUNCTION AND ALARM (LOW-FLOW, BATTERY, AND DRIVELINE FAULT ALARMS), BLEEDING, HEMORRHAGIC STROKE, SUBTHERAPEUTIC INR, RIGHT HEART FAILURE, ARRHYTHMIA, HF DECOMPENSATION/EXACERBATION, NONCARDIAC COMORBIDITIES LIKE PSYCHIATRIC, NEUROLOGIC, HYPERTENSION, RENAL DISEASE, HEPATIC DECOMPENSATION, NONCARDIAC RESPIRATORY DISTRESS, ANEMIA, NEUTROPENIA/ THROMBOCYTOPENIA, PERIPHERAL ARTERIAL COMPLICATIONS. THIS RETROSPECTIVE COHORT STUDY INCLUDED PATIENTS AGE AT LEAST 18 YEARS WITH ADVANCED HF WHO RECEIVED A PRIMARY HM3 OR WERE LISTED FOR OHT BETWEEN JANUARY 2014 AND MARCH 2021. A TOTAL OF 185 HM3 PATIENTS (49%) AND 196 OHT PATIENTS (51%) WERE EVALUATED. THE PRIMARY OUTCOME WAS 3- YEAR SURVIVAL, AND THE SECONDARY OUTCOME WAS MEAN CUMULATIVE ALL-CAUSE UNPLANNED READMISSION. UNPLANNED READMISSIONS WERE CATEGORIZED AS MANAGEMENT OF CARDIAC DISEASE, NONCARDIAC COMORBIDITIES, LVAD-RELATED COMPLICATIONS, OR TRANSPLANT-RELATED COMPLICATIONS. CARDIAC DISEASE PROGRESSION INCLUDED RIGHT HF, ARRHYTHMIA, PERICARDIAL EFFUSION, AND HF DECOMPENSATION, AS EVIDENCED BY VOLUME OVERLOAD, DYSPNEA, OR SYNCOPE. AFTER PROPENSITY SCORE MATCHING, THERE WAS NO STATISTICAL DIFFERENCE IN 3-YEAR SURVIVAL (83.7% FOR HM3 VS 87.0% FOR OHT; P ¼ .91; RELATIVE RISK [RR], 1.00; 95% CONFIDENCE INTERVAL [CI], 0.45-2.20). IN THE UNMATCHED COHORTS, PATIENTS AGE 18 TO 49 YEARS HAD COMPARABLE SURVIVAL WITH HM3 AND OHT (96.9% VS 95.9%; N ¼ 91; P ¼ 1.00; RR, 0.92; 95% CI, 0.09-9.78). PATIENTS AGE 50 YEARS HAD SLIGHTLY INFERIOR SURVIVAL WITH HM3 (75.0% VS 83.9%; N ¼ 290; P ¼ .60; RR, 1.51; 95% CI, 0.85-2.68). THE MEAN NUMBER OF READMISSIONS AT 3 YEARS WAS HIGHER IN THE HM3 GROUP (3.89 VS 2.05; P<.001). THE DETAILED ANALYSIS AND RESULTS ARE DESCRIBED IN THE ATTACHED ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217478 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death