BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21432285 · Received February 21, 2025

    Report

    Report Number
    2916596-2025-00895
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    October 1, 2024
    Report Date
    May 8, 2025
    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

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE FOLLOWING INFORMATION REGARDING THE LITERATURE REVIEW ARTICLE SHOULD HAVE BEEN INCLUDED IN H11 OF THE INITIAL REPORT: 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. LEE, V., MACFARLANE, S., & ROMANO, G. (2024). PROVIDING PHYSICAL THERAPY INTERVENTIONS FOR A PATIENT AFTER HEART TRANSPLANTATION IN THE ACUTE CARE SETTING: A CASE REPORT. JOURNAL OF ACUTE CARE PHYSICAL THERAPY, 15(4), 129-136. DOI: HTTP://DX.DOI.ORG/10.1097/JAT.0000000000000245. (B)(6) HOSPITAL, PHILADELPHIA, PA, UNITED STATES. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT COMMUNICATED/IDENTIFIED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA AND RENAL FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS ARRHYTHMIA AS A POTENTIAL LATE POST-IMPLANT COMPLICATION. 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 "PROVIDING PHYSICAL THERAPY INTERVENTIONS FOR A PATIENT AFTER HEART TRANSPLANTATION IN THE ACUTE CARE SETTING: A CASE REPORT" THAT A 60 YEAR OLD MALE IMPLANTED WITH A HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS LISTED FOR HEART TRANSPLANT. THE PATIENT HAD PAST MEDICAL HISTORY THAT INCLUDED NONISCHEMIC CARDIOMYOPATHY AND HEART FAILURE WITH REDUCED EJECTION FRACTION OF 10-15% THAT CAUSED THEM TO REQUIRE AN LVAD. OTHER SIGNIFICANT DIAGNOSES IN THE PAST INCLUDED CHRONIC KIDNEY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND COLON CANCER STATUS POST COLECTOMY WITH ILEOSTOMY. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR RECURRENT VENTRICULAR TACHYCARDIA. MEDICAL PROCEDURES ADDRESSING THE PATIENT¿S RECURRENT TACHYCARDIA WERE LEFT AND RIGHT STELLATE GANGLION BLOCK AND CARDIOVERSION. AFTER 19 DAYS IN THE HOSPITAL THE PATIENT UNDERWENT A HEART TRANSPLANT AND HAD THEIR LVAD EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634412 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| H| L