BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 11108901 · Received January 4, 2021

    Report

    Report Number
    2134265-2020-18683
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 8, 2020
    Report Date
    February 26, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM - UPDATED.

    Description of Event or Problem · 0

    REPRISE IV STUDY. IT WAS REPORTED THAT HYPO-ATTENUATING LEAFLET THICKENING OCCURRED. THE PATIENT WAS ENROLLED INTO THE REPRISE IV STUDY IN (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE PATIENT WAS NOT ON A PRIOR REGIMEN OF ASPIRIN OR OTHER ANTIPLATELET MEDICATIONS. A LOADING DOSE OF 81 MG OF ASPIRIN WAS GIVEN THE DAY OF THE PROCEDURE. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 27 MM LOTUS EDGE VALVE. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL AND COMPLETE RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). TWO DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2020, 390 DAYS POST INDEX PROCEDURE, A COMPUTED TOMOGRAPHY SCAN REVEALED HYPO-ATTENUATING LEAFLET THICKENING. NO ACTION WAS TAKEN TO TREAT THE EVENT. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED RECOVERING. IT WAS FURTHER REPORTED THAT 390 DAYS POST INDEX PROCEDURE, A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND REVEALED THAT THE 27 MM LOTUS EDGE VALVE WAS WELL-SEATED IN THE AORTIC ANNULUS. THE SCAN REVEALED THAT THE PATIENT'S LEAFLETS WERE THIN AND PLIABLE, EXCEPT FOR THE ANTERIOR-MOST LEAFLET, ADJACENT TO THE RIGHT CORONARY CUSP, WHICH HAD EVIDENCE OF HYPO-ATTENUATING LEAFLET THICKENING. THERE WAS FULL CLOSURE COAPTATION AND FULL SYSTOLIC OPENING WITH WAS NO EVIDENCE OF STRUCTURAL VALVULAR DEGENERATION OR PARAVALVULAR LEAK. THE NATIVE CUSPS WERE WELL OPACIFIED WITH NO ROOT THROMBUS NOTED. THERE WAS A BEAM HARDENING ARTIFACT OFF THE STENT FRAME, ESPECIALLY ADJACENT TO THE SUPRA-ANNULAR STENT POSTS, MILD FUSIFORM ANEURYSM OF THE ASCENDING AORTA WITH A MAX DIMENSION OF 38MM, AND SEVERELY DILATED MAIN PULMONARY ARTERY 38MM. A MEDICATION ADJUSTMENT WAS MADE TO TREAT THE EVENT.

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT HYPO-ATTENUATING LEAFLET THICKENING OCCURRED. THE PATIENT WAS ENROLLED INTO THE (B)(6) STUDY IN (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE PATIENT WAS NOT ON A PRIOR REGIMEN OF ASPIRIN OR OTHER ANTIPLATELET MEDICATIONS. A LOADING DOSE OF 81 MG OF ASPIRIN WAS GIVEN THE DAY OF THE PROCEDURE. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 27 MM LOTUS EDGE VALVE. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL AND COMPLETE RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). TWO DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2020, 390 DAYS POST INDEX PROCEDURE, A COMPUTED TOMOGRAPHY SCAN REVEALED HYPO-ATTENUATING LEAFLET THICKENING. NO ACTION WAS TAKEN TO TREAT THE EVENT. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9559 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0024336108

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other