BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20240634 · Received September 17, 2024

    Report

    Report Number
    2916596-2024-05936
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 30, 2024
    Report Date
    November 18, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE (APRIL 2022) SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. E1: REPORTER EMAIL WAS NOT AVAILABLE. AUTHOR CITATION: SHIOSE A, ET AL. THE CASE OF EXTRACORPOREAL CIRCULATION CONVERSED FROM IMPELLA TO IMPLANTABLE VENTRICULAR ASSIST DEVICE USING THE MICS APPROACH. EXTRACORPOREAL CIRCULATION TECHNOLOGY. DEPARTMENT OF CLINICAL ENGINEERING, MEDICAL TECHNOLOGY DEPARTMENT, KYUSHU UNIVERSITY HOSPITAL G2: REPORT SOURCE CORRECTED. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER: (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THROUGH THE CASE STUDY TITLED "THE CASE OF EXTRACORPOREAL CIRCULATION CONVERSED FROM IMPELLA TO IMPLANTABLE VENTRICULAR ASSIST DEVICE USING THE MICS" THAT THE PATIENT EXPERIENCED AORTIC REGURGITATION (AR) FOLLOWING TRANSFER TO THE LEFT VENTRICULAR ASSIST DEVICE FROM ANOTHER MANUFACTURER'S DEVICE. AR WAS OBSERVED FOLLOWING THE REMOVAL OF THE OTHER MANUFACTURER'S DEVICE AND THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL INTERVENTION (PARK'S STITCH). IT WAS NOTED THAT THE PATIENT WAS IN CARDIAC ARREST DURING THIS PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE GENERAL WARD ON POST OPERATIVE DAY 9. THE HOSPITAL DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER: (B)(6), WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. A, IS CURRENTLY AVAILABLE. THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, THE IFU EXPLAINS THAT MODERATE TO SEVERE AORTIC INSUFFICIENCY MUST BE CORRECTED AT THE TIME OF DEVICE IMPLANT. THIS SECTION ALSO STATES THAT IF THE AORTIC INSUFFICIENCY IS NOT ADDRESSED, THE DEVICE WILL NOT BE ABLE TO PROVIDE THE INTENDED FLOW. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD WITHDRAWAL DIFFICULTIES FROM IMPELLA, AND WAS TRANSFERRED FOR LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT. AFTER THE IMPELLA WAS STOPPED AND REMOVED FROM THE LEFT VENTRICLE, AORTIC REGURGITATION (AR) WAS OBSERVED, SO A PARK'S STITCH WAS PERFORMED. CARDIAC ARREST WAS ALSO REPORTED. THE PATIENT WAS TRANSFERRED TO THE GENERAL WARD ON POST OPERATIVE DAY 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2527119 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8129005 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other