BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19742280 · Received July 15, 2024

    Report

    Report Number
    2916596-2024-04388
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    January 1, 2023
    Report Date
    July 18, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN 2022 AND 2023. SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. BYRNE, R., FRANKEL, W., NAIR, A., CHOUDHRY, S., TUNUGUNTLA, H., ADACHI, I., DEZFULIAN, C., HICKEY, E., & BRODA, C. (2024). OUTCOMES OF COMPLEX ADULT CONGENITAL HEART DISEASE PATIENTS SUPPORTED WITH A FULLY MAGNETICALLY LEVITATED VENTRICULAR ASSIST DEVICE AT A SINGLE CENTER. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION 43(4), S498¿S499. HTTPS://DOI.ORG/10.1016/J.HEALUN.2024.02.691. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    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. FURTHERMORE, A SPECIFIC CAUSE FOR THE REPORTED DRIVELINE INFECTION COULD NOT BE DETERMINED. A REVIEW OF THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE DEVICE SERIAL NUMBERS WERE NOT COMMUNICATED/IDENTIFIED. THE HEARTMATE 3 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, INCLUDING RENAL DYSFUNCTION, RESPIRATORY FAILURE, INFECTION (LOCAL, DRIVELINE OR PUMP POCKET INFECTION), AND OTHER NEUROLOGICAL EVENTS (NOT STROKE-RELATED), THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS INFECTION AND NEUROLOGICAL DYSFUNCTION AS POTENTIAL LATE POSTIMPLANT COMPLICATIONS. CARE INSTRUCTIONS REGARDING INFECTION PREVENTION ARE PROVIDED IN VARIOUS SECTIONS OF THIS IFU, INCLUDING THE SECTION ENTITLED "PATIENT CARE AND MANAGEMENT - CONTROLLING INFECTION." SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING INFECTION PREVENTION, AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. 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 ¿OUTCOMES OF COMPLEX ADULT CONGENITAL HEART DISEASE PATIENTS SUPPORTED WITH A FULLY MAGNETICALLY LEVITATED VENTRICULAR ASSIST DEVICE AT A SINGLE CENTER¿ THAT THE USE OF FULLY MAGNETICALLY LEVITATED DURABLE VENTRICULAR ASSIST DEVICE (VAD) THERAPY WAS A VIABLE STRATEGY TO TREAT END-STAGE HEART FAILURE (HF) IN PATIENTS WITH COMPLEX ADULT CONGENITAL HEART DISEASE (ACHD). HEARTMATE 3 (HM3) MAY BE RELATED TO RENAL FAILURE, RESPIRATORY FAILURE, DRIVELINE INFECTION, AND TRANSIENT ISCHEMIC ATTACK (TIA). A RETROSPECTIVE REVIEW OF PATIENTS WITH COMPLEX ACHD AT THE TIME OF HM3 IMPLANTATION FROM 2020-2023 WAS PERFORMED. A TOTAL OF NINE PATIENTS WITH COMPLEX ACHD UNDERWENT HM3 VAD IMPLANTATION. ONE PATIENT HAD ACUTE RENAL FAILURE REQUIRING TEMPORARY DIALYSIS AND 2 PATIENTS HAD RESPIRATORY FAILURE REQUIRING TEMPORARY TRACHEOSTOMY. OVERALL, DEVICE-RELATED COMPLICATIONS WERE UNCOMMON; TWO PATIENTS (22%) DEVELOPED DRIVELINE INFECTION AND ONE PATIENT (11%) HAD A TIA. NO PATIENTS EXPERIENCED PUMP THROMBOSIS OR GASTROINTESTINAL BLEED. ONE PATIENT (11%) DIED FROM SEVERE COVID-19 INFECTION AND HF 8 MONTHS AFTER VAD IMPLANTATION. THE REMAINING PATIENTS SURVIVED WITHOUT READMISSION FOR HF. NO PATIENTS WERE LOST TO FOLLOW-UP, TRANSPLANTED, OR EXPLANTED. THE USE OF FULLY MAGNETICALLY LEVITATED DURABLE VAD THERAPY WAS A VIABLE STRATEGY TO TREAT END-STAGE HF IN PATIENTS WITH COMPLEX ACHD. ADDITIONAL DATA IS NEEDED TO DETERMINE LONG-TERM OUTCOMES FOR THIS POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458264 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention