BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10373111 · Received August 6, 2020

    Report

    Report Number
    2916596-2020-03972
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    February 15, 2020
    Report Date
    September 18, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS (INFECTION, RENAL DYSFUNCTION, AND VOLUME OVERLOAD) COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS INVESTIGATION. THE ACCOUNT COMMUNICATED THAT THE PATIENT EXPIRED ON (B)(6) 2020 (REFER TO CS-140263). THE PATIENT HAD PREVIOUSLY UNDERWENT A HEARTMATE II TO HEARTMATE 3 PUMP EXCHANGE ON (B)(6) 2019, AMID CONCERNS OF CHRONIC INFECTION (REFER TO CS-128070). PRIOR TO THE PATIENT¿S EXPIRATION, THE PATIENT WAS HOSPITALIZED OVER 15 TIMES DUE TO A CHRONIC DRIVELINE AND PUMP POCKET INFECTION. MOST OF THESE ADMISSIONS INCLUDED VOLUME OVERLOAD AND DIALYSIS RELATED ISSUES. THIS COMPLAINT ADDRESSES ADMISSION 8 OUT OF 15. NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. THE HEARTMATE 3 LVAS IFU LISTS RENAL DYSFUNCTION AND INFECTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION A2, H6 (PATIENT AND CONCLUSION CODES), AND H8: CORRECTION. CORRECTION - INTERNAL NUMBERS IN INVESTIGATION CONCLUSION REPLACED WITH MFR NUMBERS. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS (INFECTION, RENAL DYSFUNCTION, AND VOLUME OVERLOAD) COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS INVESTIGATION. THE ACCOUNT COMMUNICATED THAT THE PATIENT EXPIRED ON (B)(6) 2020, (REFER TO MFR#2916596-2020-03652). THE PATIENT HAD PREVIOUSLY UNDERWENT A HEARTMATE II TO HEARTMATE 3 PUMP EXCHANGE ON (B)(6) 2019, AMID CONCERNS OF CHRONIC INFECTION (REFER TO #MFR2916596-2019-03904). PRIOR TO THE PATIENT¿S EXPIRATION, THE PATIENT WAS HOSPITALIZED OVER 15 TIMES DUE TO A CHRONIC DRIVELINE AND PUMP POCKET INFECTION. MOST OF THESE ADMISSIONS INCLUDED VOLUME OVERLOAD AND DIALYSIS RELATED ISSUES. THIS COMPLAINT ADDRESSES ADMISSION 8 OUT OF 15. NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. THE HEARTMATE 3 LVAS IFU LISTS RENAL DYSFUNCTION AND INFECTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    EVENT DATE ESTIMATED AS ADMISSION DETAILS WERE NOT PROVIDED. DESCRIBE EVENT OR PROBLEM: THIS COMPLAINT WILL ADDRESS ADMISSION 8 OUT OF 15. THE EVENT IS BEING REPORTED CONSERVATIVELY. RELATED MANUFACTURER REPORT #'S: 2916596-2020-03961, 2916596-2020-03962, 2916596-2020-03963, 2916596-2020-03964, 2916596-2020-03969, 2916596-2020-03970, 2916596-2020-03971, 2916596-2020-03973, 2916596-2020-03975, 2916596-2020-03976, 2916596-2020-03977, 2916596-2020-03978, 2916596-2020-03979, 2916596-2020-03980. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD OVER 15 ADMISSIONS WHERE CHRONIC DRIVELINE AND PUMP POCKET INFECTION WAS ADDRESSED. IT WAS ALSO NOTED THAT MOST OF THESE ADMISSIONS WERE FOR VOLUME OVERLOAD AND DIALYSIS RELATED NEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840707 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7032579 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization