BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 11819100 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-05944
    Event Type
    Death
    Date Received
    May 13, 2021
    Date of Event
    May 1, 2007
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH, DATE OF EVENT APPROXIMATE. DATE OF EVENT OCCURRED AFTER (B)(6) 2007. LITERATURE CITATION: JUNQUERA L, FREITAS-FERRAZ AB, PADRON R, SILVA I, NUNES FERREIRA-NETO A, GUIMARAES L, MOHAMMADI S, MORIS C, PHILIPPON F, RODES-CABAU J. INTRAPROCEDURAL HIGH-DEGREE ATRIOVENTRICULAR BLOCK OR COMPLETE HEART BLOCK IN TRANSCATHETER AORTIC VALVE REPLACEMENT RECIPIENTS WITH NO PRIOR INTRAVENTRICULAR CONDUCTION DISTURBANCES. CATHETER CARDIOVASC INTERV. 2020; 95 (5): 982-90. RETRIEVED FROM HTTPS://ONLINELIBRARY.WILEY.COM/DOI/ABS/10.1002/CCD.28323.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE DEATH OCCURRED. THE OCCURRENCE OF INTRAPROCEDURAL HIGH-DEGREE ATRIOVENTRICULAR BLOCK (HAVB) OR COMPLETE HEART BLOCK (CHB) WAS ASSESSED IN 676 CONSECUTIVE PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN TWO CENTERS. TWO GROUPS WERE ESTABLISHED ACCORDING TO ITS DURATION: PERSISTENT-HAVB/CHB (PHAVB/CHB) AND TRANSIENT-HAVB/CHB (THAVB/CHB), NOT PRESENT AT THE END OF THE PROCEDURE. THE IMPLANTED VALVES INCLUDED ALL TYPES OF DELIVERY SYSTEMS AVAILABLE; NON-BOSTON SCIENTIFIC (BSC) BALLOON EXPANDABLE DELIVERY SYSTEMS, NON-BSC SELF EXPANDABLE DELIVERY SYSTEMS, ACURATE NEO VALVE SYSTEM AND MECHANICALLY EXPANDABLE LOTUS VALVE SYSTEM. THE NON-BSC BALLOON EXPANDABLE AND THE NON-BSC SELF EXPANDABLE DELIVERY SYSTEM WERE THE MOST FREQUENTLY IMPLANTED VALVE SYSTEMS. INTRAPROCEDURAL-HAVB/CHB OCCURRED IN 50 PATIENTS (7.4%), BEING PERSISTENT IN 32 (64.0%), AND TRANSIENT IN 18 (36.0%). THE USE OF A NON-BSC VALVE SYSTEM AND A GREATER OVERSIZING OF THE VALVE HAD AN INCREASED THE RISK OF INTRAPROCEDURAL-HAVB/CHB (P < 0.001). PERMANENT PACEMAKER IMPLANTATION (PPI) WAS MORE FREQUENT IN THE PHAVB/CHB THAN IN THE THAVB/CHB GROUP (96.9% VS. 33.3%; P < 0.001). TWO PATIENTS DIED BEFORE THE 30 DAY FOLLOW UP. AT 1-MONTH FOLLOW-UP, THE PHAVB/CHB GROUP SHOWED A 98% VENTRICULAR PACING RATE (VPR) COMPARED TO 16% IN THE THAVB/CHB GROUP (P < 0.001), AND SIMILAR VPR WERE OBSERVED AT 1-YEAR FOLLOW-UP (98% VS. 37%, P < 0.001). LEFT VENTRICULAR EJECTION FRACTION (LVEF) DECREASED AT 1-YEAR FOLLOW-UP IN PATIENTS WITH PHAVB/CHB (3.9 +/-1.8%, P = 0.003). AT 1 YEAR FOLLOW UP, THREE PATIENTS WITH INTRAPROCEDURAL-HAVB/CHB AND PPI HAD DIED. CONCLUSION: IN TAVR RECIPIENTS WITH NO PRIOR INTRAVENTRICULAR CONDUCTION DISTURBANCES, INTRAPROCEDURAL-HAVB/CHB OCCURRED IN 7.4% OF CASES. HAVB/CHB WAS PERSISTENT IN MOST CASES AND DETERMINED A HIGH RATE OF PPI POST-TAVR. VERY HIGH VPR AT 1- AND 12-MONTH FOLLOW-UP WERE OBSERVED, WHICH IN TURN WAS ASSOCIATED WITH A NEGATIVE EFFECT ON LVEF. THESE RESULTS SUPPORT EARLY PPI AND CLOSE FOLLOW-UP IN PATIENTS DEVELOPING INTRAPROCEDURAL-PHAVB/CHB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715001 LOTUS VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death