BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 11819111 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-05924
    Event Type
    Death
    Date Received
    May 13, 2021
    Date of Event
    May 1, 2015
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    PMA / PMN Number
    P180029
    Removal / Correction Number
    92630745-FA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH, DATE OF EVENT APPROXIMATE. EVENT OCCURRED AFTER (B)(6) 2015. LITERATURE CITATION: PATEL K, BROYD C, CHEHAB O, JERRUM M, QUEENAN H, BEDFORD K, BARAKAT F, KENNON S, OZKOR M, MATHUR A, MULLEN MJ. TRANSCATHETER AORTIC VALVE IMPLANTATION IN ACUTE DECOMPENSATED AORTIC STENOSIS. CATHETER CARDIOVASC INTERV. 2020; 96 (3): E348-E54. RETRIEVED FROM HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/31696656.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE TITLED TRANSCATHETER AORTIC VALVE IMPLANTATION IN ACUTE DECOMPENSATED AORTIC STENOSIS THAT DEATH OCCURRED. THE OBJECTIVE OF THE STUDY WAS TO ASSESS THE SAFETY AND EFFICACY OF FIRST-LINE TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN PATIENTS PRESENTING WITH ACUTE DECOMPENSATED AORTIC STENOSIS (ADAS). 893 PATIENTS (MEAN AGE 83 +/- 7, 50.5% MALE) UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) (19% ADAS, 81% ELECTIVE). ADAS PATIENTS WERE MORE UNWELL WITH WORSE ECHOCARDIOGRAPHIC PARAMETERS THAN ELECTIVE PATIENTS. ADAS PATIENTS OF 55.9% WERE KNOWN TO HAVE SIGNIFICANT AORTIC STENOSIS PRIOR TO THEIR DECOMPENSATION. TAVI DEVICES USED WERE LOTUS VALVE SYSTEM, LOTUS EDGE VALVE SYSTEM, ACURATE NEO VALVE SYSTEM OR NON-BOSTON SCIENTIFIC (BSC) VALVE SYSTEM. THE MAJORITY OF PATIENTS IN BOTH COHORTS HAD NON-BSC VALVES IMPLANTED. PROCEDURAL MORTALITY WAS NOT DIFFERENT BETWEEN THE ADAS AND ELECTIVE COHORTS. THE ADAS COHORT HAD A HIGHER 30-DAY MORTALITY AND HOSPITAL LONGER LENGTH OF STAY. MULTIVARIATE ANALYSIS IDENTIFIED ACUTE KIDNEY INJURY AND ADAS AS SIGNIFICANT PREDICTORS OF 30-DAY MORTALITY. IN CONCLUSION THE STUDY SUMMARIZED TAVI FOR ADAS IS SAFE AND EFFECTIVE WITH PROCEDURAL OUTCOMES SIMILAR TO ELECTIVE PATIENTS. HOWEVER, COMPARED TO ELECTIVE PATIENTS, THEY HAVE WORSE PHYSIOLOGICAL BASELINE FEATURES, POORER PROGNOSIS AT 30 DAYS, AND LONGER HOSPITAL ADMISSIONS. MAJORITY OF PATIENTS WHO PRESENTED WITH ADAS WERE KNOWN TO HAVE AORTIC STENOSIS PRIOR TO ADMISSION. THE INFORMATION PROVIDED IN THE LITERATURE ARTICLE DID NOT IDENTIFY WHICH INCIDENTS OCCURRED WITH WHICH SPECIFIC VALVE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715320 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death