BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21929955 · Received April 29, 2025

    Report

    Report Number
    2916596-2025-02729
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    February 3, 2023
    Report Date
    April 29, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT THE TIME OF THE EVENT. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. SECTION B3: DATE OF EVENT HAS BEEN LISTED AS 02FEB2023 AS PATIENTS WERE IMPLANTED BETWEEN 03APR2018 AND 02FEB2023. AUTHOR INFORMATION: AMDANI, S. ET AL. (2025). OUTCOMES FOR CHILDREN WITH CONGENITAL HEART DISEASE UNDERGOING VENTRICULAR ASSIST DEVICE IMPLANTATION. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 85(8), 804¿814. HTTPS://DOI.ORG/10.1016/J.JACC.2024.10.083. CLEVELAND CLINIC CHILDREN¿S, CLEVELAND, OHIO, USA; CINCINNATI CHILDREN¿S HOSPITAL, CINCINNATI, OHIO, USA; ANN & ROBERT H. LURIE CHILDREN¿S HOSPITAL OF CHICAGO, NORTHWESTERN UNIVERSITY, CHICAGO, ILLINOIS, USA; LUCILE PACKARD CHILDREN¿S HOSPITAL, STANFORD UNIVERSITY, PALO ALTO, CALIFORNIA, USA; CINCINNATI CHILDREN¿S HOSPITAL MEDICAL CENTER, UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE, CINCINNATI, OHIO, USA; AND THE UNIVERSITY OF PENNSYLVANIA PERELMAN SCHOOL OF MEDICINE, CHILDREN¿S HOSPITAL OF PHILADELPHIA, PHILADELPHIA, PENNSYLVANIA, USA. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE RESEARCH ARTICLE TITLED ¿OUTCOMES FOR CHILDREN WITH CONGENITAL HEART DISEASE UNDERGOING VENTRICULAR ASSIST DEVICE IMPLANTATION,¿ WAS RECEIVED. THE STUDY SOUGHT TO EVALUATE DIFFERENCES IN VENTRICULAR ASSIST DEVICE (VAD) OUTCOMES FOR CHILDREN WITH CONGENITAL HEART DISEASE (CHD) TO THOSE WITH NON-CHD AS WELL AS THOSE WITH UNIVENTRICULAR (UNI) CHD TO THOSE WITH BIVENTRICULAR (BI) CHD. 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 3 LVAS INSTRUCTIONS FOR USE (IFU), REVISION D, AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING STROKE, OTHER NEUROLOGICAL EVENTS (NOT STROKE RELATED), BLEEDING, INFECTION, SEPSIS RENAL FAILURE, HEPATIC DYSFUNCTION, RESPIRATORY FAILURE, CARDIAC ARRYTHMIA, AND HEMOLYSIS, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 6 OF THE IFU (UNDER "ONGOING PATIENT ASSESSMENT AND CARE"), INCLUDES A LIST OF HEARTMATE 3 PATIENT ASSESSMENTS AND LISTS NEUROLOGICAL DYSFUNCTION, INFECTION AND ARRYTHMIA AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS. FURTHERMORE, SEVERAL SECTIONS OF THE HM3 IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. 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 ¿OUTCOMES FOR CHILDREN WITH CONGENITAL HEART DISEASE UNDERGOING VENTRICULAR ASSIST DEVICE IMPLANTATION¿ IDENTIFYING THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH STROKE AND OTHER NEUROLOGICAL DYSFUNCTION, MAJOR BLEEDING, MAJOR INFECTION, RENAL AND HEPATIC DYSFUNCTION, ARRHYTHMIA, HEMOLYSIS, RESPIRATORY FAILURE, DEVICE MALFUNCTION, AND DEATH. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE DIFFERENCES IN POST-VENTRICULAR ASSIST DEVICE (VAD) IMPLANTATION MORBIDITY AND MORTALITY FOR CHILDREN WITH CONGENITAL HEART DISEASE (CHD) COMPARED TO THOSE WITH NON-CHD, AS WELL AS DIFFERENCE IN MORBIDITY AND MORTALITY AMONG CHILDREN WITH BIVENTRICULAR CHD (BI-CHD) VS. UNIVENTRICULAR CHD (UNI-CHD). PEDIATRIC PATIENTS YOUNGER THAN 19 YEARS OLD FROM MULTIPLE CENTERS ENROLLED IN THE ADVANCED CARDIAC THERAPIES IMPROVING OUTCOMES NETWORK (ACTION) AND IMPLANTED WITH A VAD FROM 03APR2018 AND 02FEB2023 WERE INCLUDED WITH A MEDIAN FOLLOW-UP DURATION OF 2.6 MONTHS. THE MEDIAN AGE WAS 4.4 YEARS, THE MAJORITY (55.7%) WERE MALE, AND INTERMACS 1 (31.4%) AND 2 (53%). OUT OF 966 PATIENTS, 352 HAD CHD AND 614 HAD NON-CHD. OF THE 352 CHD PATIENTS, 230 HAD UNI-CHD AND 122 HAD BI-CHD, AND A TOTAL OF 33 PATIENTS WERE IMPLANTED WITH HM3. OF THE 614 NON-CHD PATIENTS, THE MAJORITY HAD DILATED CARDIOMYOPATHY OR MYOCARDITIS (499; 81.3%), AND A TOTAL OF 162 PATIENTS WERE IMPLANTED WITH HM3. OUTCOMES WERE NOT BROKEN DOWN BY VAD TYPE. RESULTS FOUND THAT CHD PATIENTS WERE MORE LIKELY TO EXPERIENCE STROKE (0.62 VS. 0.37 EVENTS PER PATIENT YEAR (EPPY)), OTHER NEUROLOGICAL DYSFUNCTION (0.27 VS. 0.12 EPPY), MAJOR BLEEDING (1.4 VS. 0.64 EPPY), MAJOR INFECTION (2.02 VS. 1.15 EPPY), RENAL DYSFUNCTION (0.36 VS 0.15 EPPY), HEPATIC DYSFUNCTION (0.23 VS 0.04 EPPY), RESPIRATORY FAILURE (0.71 VS. 0.24 EPPY), AND DEVICE MALFUNCTION (0.46 VS. 0.24 EPPY) (P < 0.001 FOR ALL). RESULTS FOR STROKE BETWEEN CHD AND NON-CHD PATIENTS NOTED HEMORRHAGIC (0.11 VS. 0.04 EPPY), ISCHEMIC (0.44 VS. 0.27 EPPY), AND ISCHEMIC WITH HEMORRHAGIC CONVERSION (0.04 VS. 0.02 EPPY). OTHER NEUROLOGICAL DYSFUNCTION EVENTS INCLUDED EXTRA-AXIAL HEMORRHAGIC DYSFUNCTION (0.13 VS. 0.06 EPPY), ACUTE ENCEPHALOPATHY (0.05 VS. 0.01 EPPY), HYPOXIC-ISCHEMIC ENCEPHALOPATHY (0.05 VS. 0.02 EPPY), AND TRANSIENT ISCHEMIC ATTACK (0.04 VS. 0.02 EPPY). RESULTS FOR INFECTION NOTED SEPSIS (0.83 VS. 0.38 EPPY), MEDIASTINITIS (0.16 VS. 0.03 EPPY), AND LOCALIZED NON-DEVICE RELATED INFECTION (0.84 VS. 0.43 EPPY). SUSTAINED SUPRAVENTRICULAR TACHYCARDIA (SVT) AND SUSTAINED VT REQUIRING DRUG TREATMENT OR CARDIOVERSION DID NOT DIFFER SIGNIFICANTLY BETWEEN CHD AND NON-CHD GROUPS. HEMOLYSIS OCCURRED AT A RATE OF 0.50 VS. 0.31 EPPY (P = 0.006). CHD PATIENTS ALSO HAD WORSE ADJUSTED SURVIVAL (91 VS. 51, P < 0.001). RESULTS ALSO FOUND THAT BI-CHD PATIENTS WERE MORE LIKELY TO EXPERIENCE MAJOR BLEEDING (1.95 VS. 1.19 EPPY) (P = 0.002); HOWEVER, RATES OF STROKE, MAJOR INFECTION, RENAL AND HEPATIC DYSFUNCTION, DEVICE MALFUNCTION, AND RESPIRATORY FAILURE WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN BOTH GROUPS (P > 0.05 FOR ALL). THERE WERE NO DIFFERENCES IN ADJUSTED SURVIVAL IN UNI-CHD VS. BI-CHD PATIENTS (P > 0.05).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222385 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R