BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19094000 · Received April 11, 2024

    Report

    Report Number
    2916596-2024-02128
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 1, 2023
    Report Date
    May 31, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDWATCH FORM MW 5152794 WAS RECEIVED ON 02APR2024. SECTION A: PATIENT INFORMATION WAS MISSING. INFORMATION WAS REQUESTED. THE EVENT DATE WAS ESTIMATED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTIONS D1: CORRECTED. SECTION D4: CORRECTED CATALOG NUMBER AND UDI. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED AORTIC ANEURYSM COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) REV. C, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION,¿ LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    A MEDWATCH FORM MW 5152794 WAS RECEIVED ON 02APR2024 AND REPORTED THAT THE PATIENT HAD A HISTORY OF ABDOMINAL AORTIC ANEURYSM (AAA) IN 2023. THE PATIENT HAD A GRAFT AND STENT PLACED IN 2024. AN ANGIOGRAM WAS PERFORMED WHICH CAPTURED THE OUTFLOW GRAFT STENT PLACEMENT. THE EVENT DATE WAS ESTIMATED.

    Description of Event or Problem · 0

    THE PATIENT'S OUTFLOW GRAFT STENTING PROCEDURE WAS REPORTED UNDER MFR #: 2916596-2024-00355.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508725 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6605486

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| L