BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21114656 · Received January 9, 2025

    Report

    Report Number
    2916596-2025-00174
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    January 1, 2021
    Report Date
    January 9, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS 01JAN2024 AS DATA WAS COLLECTED BETWEEN 2017 AND 2021. AUTHOR CITATION: B.E. FERRELL, D. GOLDSTEIN. J.A. OLIVERA, R. ZHU, I.O. FAITH, S. PATEL. (2024). UTILIZATION OF DISTRESSED COMMUNITIES INDEX TO EXAMINE THE IMPACT OF SOCIOECONOMIC STATUS ON LEFT VENTRICULAR ASSIST DEVICE OUTCOMES. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION 43(4)254. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS THE ADVERSE EVENTS, INCLUDING BLEEDING, STROKE, AND INFECTION, THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. BOTH THE IFU AND PATIENT HANDBOOK CONTAIN VARIOUS SECTIONS REGARDING INFECTION AND HOW TO PREVENT IT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISTRESSED COMMUNITY INDEX (DCI) IS A MODEL OF SOCIAL VULNERABILITY THAT ASSIGNS A SCORE FROM 0 (NOT DISTRESSED) TO 100 (SEVERELY DISTRESSED) TO A ZIP CODE BASED ON SEVERAL SOCIOECONOMIC STATUS (SES) DETERMINANTS. DCI WAS USED TO EVALUATE THE IMPACT OF SES ON PREOPERATIVE CHARACTERISTICS AND ONE YEAR POSTOPERATIVE OUTCOMES OF LEFT VENTRICULAR ASSIST DEVICE (LVAD) RECIPIENTS. THIS IS A RETROSPECTIVE COHORT STUDY. PATIENTS WERE STRATIFIED BY THEIR ZIP CODE AS BEING DISTRESSED (DS), DCI > 60, OR NOT DISTRESSED (ND), DCI <60. A TOTAL OF 125 PTS MET CRITERIA FOR INCLUSION- 45 (36%) ND AND 80 (64%) DS LVAD RECIPIENTS. BASELINE DEMOGRAPHICS WERE LARGELY SIMILAR, AND BOTH GROUPS WERE PREDOMINANTLY MALE (87% ND, 78% DS). A GREATER PORTION OF THE DS COHORT IDENTIFIED AS HISPANIC (38% VS 11%, P = 0.007) AND WERE INDICATED AS DESTINATION THERAPY (84% VS 71%, P = 0.03). PREIMPLANTATION, THE DS COHORT HAD A LOWER CARDIAC INDEX (1.7 VS 2 L/ MINUTE/M 2, P = 0.02). THERE WAS NOT A SIGNIFICANT DIFFERENCE IN THE IMMEDIATE POSTOPERATIVE COURSE- HOURS INTUBATED (22 ND, 24 DS), DAYS IN THE ICU (8 ND, 8 DS), AND LENGTH OF STAY (21 ND, 22 DS). THIRTY DAY (87% ND, 94% DS) AND 1 YEAR (80% ND, 84% DS) SURVIVAL WERE SIMILAR BETWEEN GROUPS, WITH MOST PATIENTS BEING DISCHARGED DIRECTLY HOME (47% ND, 58% DS). THE DS COHORT HAD A HIGHER RATE OF REHOSPITALIZATION IN THE FIRST YEAR (61% VS 43%, P=0.04). THERE WAS NO DIFFERENCE IN BLEEDING EVENTS (33% ND, 41% DS) OR CEREBROVASCULAR ACCIDENTS (11% ND, 12% DS), THOUGH THE DS COHORT WAS MORE LIKELY TO DEVELOP A MAJOR INFECTION (66% VS 47%, P=0.03). WHILE DCI WAS ASSOCIATED WITH SOME DIFFERENCES IN BASELINE CLINICAL PROFILE, IT WAS NOT ASSOCIATED WITH DIFFERENCES IN SURVIVAL IN PATIENTS UNDERGOING LVAD IMPLANTATION. DCI, AS A MARKER OF SES, WAS INDICATIVE OF REHOSPITALIZATIONS AND MAJOR INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352619 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| L