BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21404780 · Received February 18, 2025

    Report

    Report Number
    2916596-2025-00965
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    August 1, 2022
    Report Date
    February 18, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 01AUG2022 AS DATA WAS COLLECTED BETWEEN OCTOBER 2015 AND AUGUST 2022. AUTHOR INFORMATION: LERMAN, J. B., PATEL, C. B., CASALINOVA, S., NICOARA, A., HOLLEY, C. L., LEACCHE, M., SILVESTRY, S., ZUCKERMANN, A., D¿ALESSANDRO, D. A., MILANO, C. A., SCHRODER, J. N., & DEVORE, A. D. (2024). EARLY OUTCOMES IN PATIENTS WITH LVAD UNDERGOING HEART TRANSPLANT VIA USE OF THE SHERPAPAK CARDIAC TRANSPORT SYSTEM. CIRCULATION HEART FAILURE, 17(5). HTTPS://DOI.ORG/10.1161/CIRCHEARTFAILURE.123.010904 DEPARTMENT OF MEDICINE, DIVISION OF CARDIOLOGY AND DEPARTMENT OF SURGERY, DIVISION OF CARDIOVASCULAR AND THORACIC SURGERY, DUKE UNIVERSITY HOSPITAL, DURHAM, NC. DIVISION OF CARDIOTHORACIC SURGERY, COREWELL HEALTH, GRAND RAPIDS, MI. DEPARTMENT OF CARDIOTHORACIC SURGERY, ADVENTHEALTH TRANSPLANT INSTITUTE, ORLANDO, FL. DEPARTMENT OF CARDIAC SURGERY, MEDICAL UNIVERSITY OF VIENNA, AUSTRIA. DIVISION OF CARDIAC SURGERY, DEPARTMENT OF SURGERY, MASSACHUSETTS GENERAL HOSPITAL, BOSTON. MANUFACTURER¿S INVESTIGATION CONCLUSION: THE ARTICLE REPORTED THAT THERE WERE MULTIPLE PATIENTS WHO RECEIVED A HEART TRANSPLANT. A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE EVENT(S) LEADING TO AND FOLLOWING TRANSPLANT COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WERE NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED, THE IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE 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

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "EARLY OUTCOMES IN PATIENTS WITH LVAD UNDERGOING HEART TRANSPLANT VIA USE OF THE SHERPAPAK CARDIAC TRANSPORT SYSTEM" THAT HEARTMATE 3 PATIENTS UNDERWENT HEART TRANSPLANT. THE GLOBAL UTILIZATION AND REGISTRY DATABASE FOR IMPROVED HEART PRESERVATION (GUARDIAN-HEART) REGISTRY IS AN INTERNATIONAL, MULTICENTER RETROSPECTIVE REGISTRY ASSESSING CLINICAL OUTCOMES AFTER HEART TRANSPLANTATION COMPARING 2 METHODOLOGIES OF HYPOTHERMIC STORAGE: SHERPAPAK AND TRADITIONAL COLD STORAGE. A RETROSPECTIVE REVIEW OF ALL PATIENTS WITH DURABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD) IN THE UNITED STATES WHO UNDERWENT HEART TRANSPLANT (HT) WITHIN THE REGISTRY, FROM OCT2015 TO AUG2022, ACROSS 14 STUDY CENTERS, WAS PERFORMED. ALL RECIPIENTS INCLUDED IN THIS ANALYSIS HAD A DURABLE LVAD AT THE TIME OF HT. THESE INCLUDED THE HEARTMATE II AND HEARTMATE 3 (ABBOTT) AND HVAD (MEDTRONIC). ADDITIONAL RECIPIENT BASE LINE CHARACTERISTICS THAT WERE COLLECTED INCLUDED AGE, SEX, BODY MASS INDEX, BASELINE LEFT VENTRICLE EJECTION FRACTION, TOTAL WAITLIST TIME, AND UTILIZATION OF TEMPORARY MECHANICAL CIRCULATORY SUPPORT (MCS), INCLUDING INTRA-AORTIC BALLOON PUMP (IABP), EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO), OR TEMPORARY VAD. THERE WERE 327 PATIENTS WITH DURABLE LVAD INCLUDED IN THIS ANALYSIS, 45.6% (N=149) WHO HAD ORGAN PRESERVATION WITH THE SHERPAPAK. THE SHERPAPAK PATIENTS HAD HIGHER (WORSE) PRE-HT INDEX FOR MORTALITY PREDICTION AFTER CARDIAC TRANSPLANTATION SCORES (SHERPAPAK 6.7±5.0 VERSUS TRADITIONAL COLD STORAGE 5.3±3.9; P=0.007) AND HIGHER RATES OF PRE-HT ECMO OR TEMPORARY LVAD USAGE (SHERPAPAK 10.1% VERSUS TRADITIONAL COLD STORAGE 3.4%; P=0.022). PATIENTS BRIDGED TO HT WITH A DURABLE LVAD HAD AN INCREASED RISK FOR PRIMARY GRAFT DYSFUNCTION (PGD) AND DECREASED POST-HT SURVIVAL. THESE ASSOCIATIONS ARE LIKELY DRIVEN BY MULTIPLE FACTORS, INCLUDING THE HIGHER LEVEL OF OPERATIVE COMPLEXITY REQUIRED FOR HT SURGERY IN PATIENTS WITH LVAD AND RESULTANT PROLONGED ISCHEMIC TIMES. PATIENTS WITH LVAD WHO RECEIVE HT AT A HIGHER PRIORITY STATUS (UNITED NETWORK FOR ORGAN SHARING STATUS 2 OR 1) DO SO IN THE PRESENCE OF SIGNIFICANT LVAD COMPLICATIONS, WHICH FURTHER INCREASE THEIR RISK FOR POOR POST-HT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2670657 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention