BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20979134 · Received December 19, 2024

    Report

    Report Number
    2916596-2024-52840
    Event Type
    Death
    Date Received
    December 19, 2024
    Date of Event
    February 1, 2023
    Report Date
    December 19, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    003

    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 01FEB2023 SINCE THE PATIENTS WERE IMPLANTED BETWEEN JANUARY 2010 AND FEBRUARY 2023. DEPARTMENT OF CARDIOLOGY, MEDSTAR HEART AND VASCULAR INSTITUTE, MEDSTAR WASHINGTON HOSPITAL CENTER/MEDSTAR GEORGETOWN UNIVERSITY HOSPITAL CENTER, WASHINGTON, DC, USA RYAN WALLACE, ET AL. CARDIOVASCULAR REVASCULARIZATION MEDICINE ¿ IN PRESS. HTTP://DX.DOI.ORG/10.1016/J.CARREV.2024.05.017. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AND OTHER SPECIFIC CASE/PATIENT INFORMATION ARE NOT AVAILABLE AND WERE NOT REQUESTED. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE DEVICE SERIAL NUMBERS OR OTHER IDENTIFYING INFORMATION OF THE PRODUCTS WERE NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE, REV. C AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. D ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE AND DEATH, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEARTMATE 3 (HM3) WAS ASSOCIATED WITH OUTFLOW GRAFT OBSTRUCTION (OGO), OGO ASSOCIATED TO KINKED OUTFLOW GRAFT, LOW FLOW ALARMS DUE OGO, TRANSPLANT AND A DEATH DUE REFRACTORY RIGHT VENTRICULAR FAILURE AND CARDIOGENIC SHOCK. THESE EXPERIENCES WERE REPORTED THROUGH THE RESEARCH ARTICLE TITLED ¿PERCUTANEOUS ENDOVASCULAR INTERVENTION FOR LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT OBSTRUCTION: A SINGLE-CENTER EXPERIENCE¿. THIS RETROSPECTIVE STUDY INCLUDED A TOTAL OF 12 PATIENTS IMPLANTED WITH LVAD BETWEEN JANUARY 2010 AND FEBRUARY 2023 WHO HAD 14 CASES OF OGO. FROM THIS TOTAL, ONLY 1 WAS IMPLANTED WITH HM3. THE MOST COMMON ETIOLOGY APPEARED TO BE ATTRIBUTED TO INTERRUPTION OF ANTIPLATELET THERAPY OR ANTICOAGULATION, BUT SIMILAR NUMBERS WERE FOUND FOR OTHER ETIOLOGIES, INCLUDING KINKS OF THE OUTFLOW GRAFT, BUILDUP OF GELATINOUS MATERIAL IN BETWEEN THE OUTFLOW GRAFT AND EXTERNAL WRAP CAUSING EXTERNAL COMPRESSION, AND UNDETERMINED CAUSE. ALL PATIENTS UNDERWENT INVASIVE ANGIOGRAPHY WITH BALLOON ANGIOPLASTY AND STENTING. AT LONG-TERM FOLLOW-UP, 6 OUT OF 12 PATIENTS WERE ALIVE. ONE PATIENT DIED WITHIN 30 DAYS OF PERCUTANEOUS ENDOVASCULAR INTERVENTION; THE CAUSE WAS REFRACTORY RIGHT VENTRICULAR FAILURE AND CARDIOGENIC SHOCK. A TOTAL OF SIX PATIENTS UNDERWENT LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT AS A BRIDGE TO TRANSPLANTATION; OF THESE, THREE PATIENTS UNDERWENT ORTHOTOPIC HEART TRANSPLANT DURING THE STUDY PERIOD, WHILE TWO PATIENTS DIED, AND ONE IS STILL AWAITING ORTHOTOPIC HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115423 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death