BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 10953227 · Received December 5, 2020

    Report

    Report Number
    2134265-2020-16911
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM: UPDATED. B6 RELEVANT TESTS/LABORATORY DATA - UPDATED. H6:PATIENT CODES: UPDATED. H3: DEVICE EVAL BY MANUFACTURER: PROCEDURAL IMAGING WAS PROVIDED TO ASSIST IN THE INVESTIGATION AND WAS REVIEWED BY A BOSTON SCIENTIFIC QUALITY ENGINEER. THE AVAILABLE MEDIA SHOWS 60 SERIES FROM A TRANSCATHETER AORTIC VALVE IMPLANTATION. THE FIRST VALVE IS A 27MM LOTUS EDGE VALVE AND IS POSITIONED AT THE ANNULUS WITH A SEVERE WAIST. THE 27MM LOTUS EDGE VALVE IS REPLACED WITH A 25MM LOTUS EDGE VALVE. THE 25MM LOTUS EDGE VALVE IS POSITIONED HIGH IN THE AORTA, WITH A SUITABLE WAIST. THE MEDIA PROVIDED SHOWS NO VISIBLE EVIDENCE OF VALVULAR INSUFFICIENCY. THE IMAGE QUALITY IS POOR IN ALL SERIES. A CONTRAST SHOT PERFORMED IN SERIES 52 WITH FAINT CORONARY PERFUSION VISIBLE. THERE WERE NO RECORDINGS OF THE RELEASED LOTUS EDGE VALVE IN ITS FINAL POSITION. THE REPORTED EVENT OCCURRED 453 DAYS POST INDEX PROCEDURE, THEREFORE, CANNOT BE CONFIRMED FROM THE MEDIA OF THE INDEX PROCEDURE.

    Additional Manufacturer Narrative · 0

    H3: DEVICE EVAL BY MANUFACTURER: PROCEDURAL IMAGING WAS PROVIDED TO ASSIST IN THE INVESTIGATION AND WAS REVIEWED BY A BOSTON SCIENTIFIC QUALITY ENGINEER. THE AVAILABLE MEDIA SHOWS 60 SERIES FROM A TRANSCATHETER AORTIC VALVE IMPLANTATION. THE FIRST VALVE IS A 27MM LOTUS EDGE VALVE AND IS POSITIONED AT THE ANNULUS WITH A SEVERE WAIST. THE 27MM LOTUS EDGE VALVE IS REPLACED WITH A 25MM LOTUS EDGE VALVE. THE 25MM LOTUS EDGE VALVE IS POSITIONED HIGH IN THE AORTA, WITH A SUITABLE WAIST. THE MEDIA PROVIDED SHOWS NO VISIBLE EVIDENCE OF VALVULAR INSUFFICIENCY. THE IMAGE QUALITY IS POOR IN ALL SERIES. A CONTRAST SHOT PERFORMED IN SERIES 52 WITH FAINT CORONARY PERFUSION VISIBLE. THERE WERE NO RECORDINGS OF THE RELEASED LOTUS EDGE VALVE IN ITS FINAL POSITION. THE REPORTED EVENT OCCURRED 453 DAYS POST INDEX PROCEDURE, THEREFORE, CANNOT BE CONFIRMED FROM THE MEDIA OF THE INDEX PROCEDURE.

    Description of Event or Problem · 0

    REPRISE IV LOTUS EDGE POST MARKET STUDY IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, HEPARIN OR ANOTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS NOT ON A REGIMEN OF ASPIRIN OR ANTIPLATELET MEDICATION OTHER THAN ASPIRIN AT THE TIME OF THE INDEX PROCEDURE. A LOTUS INTRODUCER SHEATH(LIS) WAS PLACED AND THEN THE NATIVE AORTIC VALVE WAS TREATED WITH BALLOON AORTIC VALVULOPLASTY(BAV), ACCORDING TO THE INSTRUCTIONS FOR USE(IFU). OF NOTE, A NEW CONDUCTION DISTURBANCE (LEFT BUNDLE BRANCH BLOCK) WAS NOTED POST BAV. A 27 MM LOTUS EDGE VALVE WAS THEN INSERTED, HOWEVER WAS NOT-IMPLANTED SINCE THE VALVE WAS OVER-SIZED. THE 27 MM LOTUS EDGE VALVE WAS RETRIEVED AND EXCHANGED FOR A 25 MM LOTUS EDGE VALVE WHICH WAS DEPLOYED SUCCESSFULLY INTO THE PROPER ANATOMICAL LOCATION. TWO DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND OTHER ANTICOAGULANTS. POST PROCEDURE EVENT SUMMARY: ON (B)(6) 2020, 453 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH LEFT MAIN CORONARY OBSTRUCTION BY THE NATIVE LEFT LEAFLET. COMPUTERIZED TOMOGRAPHY(CT) SCAN, ECHOCARDIOGRAM, AND LAB TESTS WERE PERFORMED AS THE DIAGNOSTIC PROCEDURES. THE SUBJECT WAS HOSPITALIZED FOR THE EVENTS AND THE 25 MM LOTUS EDGE VALVE WAS EXPLANTED AND REPLACED WITH NON-BOSTON SCIENTIFIC(BSC) VALVE WITH AORTIC ROOT ENLARGEMENT. THE EVENT WAS CONSIDERED RECOVERED THE FOLLOWING DAY. IT WAS FURTHER REPORTED THAT: ON (B)(6) 2020, 444 DAYS POST INDEX PROCEDURE THE SUBJECT DEVELOPED NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2020, 451 DAYS, POST INDEX PROCEDURE, THE SUBJECT WHO WAS MORBIDLY OBESE PRESENTED TO THE EMERGENCY DEPARTMENT WITH LEFT-SIDED CHEST PAIN AND LEFT ARM NUMBNESS. PREVIOUSLY, THE SUBJECT WAS HOSPITALIZED FOR THE SAME REASON AND WENT FOR CARDIAC CATHERIZATION. ON THE SAME DAY, THE SUBJECT WAS NOTED WITH MECHANICAL OBSTRUCTION OF CORONARY SINUSES BY THE LOTUS EDGE VALVE AND ELECTROCARDIOGRAM(ECG) 12-LEAD ED SHOWED THE ST SEGMENT DEPRESSION. CT OF THE CHEST SHOWED NO PULMONARY EMBOLISM. DURING THIS TIME, ASPIRIN WAS ADMINISTERED AND LAB RESULTS SHOWED THE ELEVATED TROPONIN I VALUE AT 0.30, LATER TROPONIN VALUE ELEVATED TO 3.35. 2D TRANSTHORACIC ECHOCARDIOGRAM(TTE) REVEALED LEFT VENTRICLE MODERATELY INCREASED WALL THICKNESS, DIASTOLIC DYSFUNCTION, MITRAL VALVE REGURGITATION AND INCREASED GRADIENT WAS NOTED. ON (B)(6) 2020, CT CORONARY ANGIOGRAM REVEALED THAT THE PRIOR TRANSCATHETER AORTIC VALVE REPLACEMENT(LOTUS EDGE VALVE) HAD OBLITERATED THE RIGHT AORTIC SINUS JAILING THE ORIGIN OF THE NON ADMITTED RIGHT CORONARY ARTERY(RCA) AND ALSO CAUSED LEFT AORTIC SINUS WHICH GIVES ORIGIN INDIVIDUALLY TO LEFT ANTERIOR DESCENDING ARTERY AND LEFT CIRCUMFLEX ARTERY (DUAL OSTIA). THE SUBJECT WAS TREATED WITH HEPARIN DRIP DUE TO THE MI AND ASPIRIN ATORVASTATIN WERE CONTINUED DUE TO MECHANICAL OBSTRUCTION OF CORONARY SINUSES BY THE LOTUS EDGE VALVE. ON (B)(6) 2020, THE MYOCARDIAL INFARCTION WAS CONSIDERED RECOVERED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND OTHER COAGULANTS. IT WAS FURTHER REPORTED THAT: DURING THE PREVIOUS HOSPITALIZATION FOR CARDIAC CATHERIZATION, THE PATIENT HAD AN OUTSIDE CATHETERIZATION WITH NO STENT AND NO OTHER FINDINGS. ON (B)(6) 2020, COMPUTED TOMOGRAPHY ANGIOGRAPHY(CTA) REVEALED NO LEAFLET THROMBOSIS.

    Description of Event or Problem · 0

    REPRISE IV LOTUS EDGE POST MARKET STUDY. IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, HEPARIN OR ANOTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS NOT ON A REGIMEN OF ASPIRIN OR ANTIPLATELET MEDICATION OTHER THAN ASPIRIN AT THE TIME OF THE INDEX PROCEDURE. A LOTUS INTRODUCER SHEATH(LIS) WAS PLACED AND THEN THE NATIVE AORTIC VALVE WAS TREATED WITH BALLOON AORTIC VALVULOPLASTY(BAV), ACCORDING TO THE INSTRUCTIONS FOR USE(IFU). OF NOTE, A NEW CONDUCTION DISTURBANCE (LEFT BUNDLE BRANCH BLOCK) WAS NOTED POST BAV. A 27 MM LOTUS EDGE VALVE WAS THEN INSERTED, HOWEVER WAS NOT-IMPLANTED SINCE THE VALVE WAS OVER-SIZED. THE 27 MM LOTUS EDGE VALVE WAS RETRIEVED AND EXCHANGED FOR A 25 MM LOTUS EDGE VALVE WHICH WAS DEPLOYED SUCCESSFULLY INTO THE PROPER ANATOMICAL LOCATION. TWO DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND OTHER ANTICOAGULANTS. POST PROCEDURE EVENT SUMMARY: ON (B)(6) 2020, 453 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH LEFT MAIN CORONARY OBSTRUCTION BY THE NATIVE LEFT LEAFLET. COMPUTERIZED TOMOGRAPHY(CT) SCAN, ECHOCARDIOGRAM, AND LAB TESTS WERE PERFORMED AS THE DIAGNOSTIC PROCEDURES. THE SUBJECT WAS HOSPITALIZED FOR THE EVENTS AND THE 25 MM LOTUS EDGE VALVE WAS EXPLANTED AND REPLACED WITH NON-BOSTON SCIENTIFIC(BSC) VALVE WITH AORTIC ROOT ENLARGEMENT. THE EVENT WAS CONSIDERED RECOVERED THE FOLLOWING DAY. IT WAS FURTHER REPORTED THAT: ON (B)(6) 2020, 444 DAYS POST INDEX PROCEDURE THE SUBJECT DEVELOPED NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2020, 451 DAYS, POST INDEX PROCEDURE, THE SUBJECT WHO WAS MORBIDLY OBESE PRESENTED TO THE EMERGENCY DEPARTMENT WITH LEFT-SIDED CHEST PAIN AND LEFT ARM NUMBNESS. PREVIOUSLY, THE SUBJECT WAS HOSPITALIZED FOR THE SAME REASON AND WENT FOR CARDIAC CATHERIZATION. ON THE SAME DAY, THE SUBJECT WAS NOTED WITH MECHANICAL OBSTRUCTION OF CORONARY SINUSES BY THE LOTUS EDGE VALVE AND ELECTROCARDIOGRAM(ECG) 12-LEAD ED SHOWED THE ST SEGMENT DEPRESSION. CT OF THE CHEST SHOWED NO PULMONARY EMBOLISM. DURING THIS TIME, ASPIRIN WAS ADMINISTERED AND LAB RESULTS SHOWED THE ELEVATED TROPONIN I VALUE AT 0.30, LATER TROPONIN VALUE ELEVATED TO 3.35. 2D TRANSTHORACIC ECHOCARDIOGRAM(TTE) REVEALED LEFT VENTRICLE MODERATELY INCREASED WALL THICKNESS, DIASTOLIC DYSFUNCTION, MITRAL VALVE REGURGITATION AND INCREASED GRADIENT WAS NOTED. ON (B)(6) 2020, CT CORONARY ANGIOGRAM REVEALED THAT THE PRIOR TRANSCATHETER AORTIC VALVE REPLACEMENT(LOTUS EDGE VALVE) HAD OBLITERATED THE RIGHT AORTIC SINUS JAILING THE ORIGIN OF THE NON ADMITTED RIGHT CORONARY ARTERY(RCA) AND ALSO CAUSED LEFT AORTIC SINUS WHICH GIVES ORIGIN INDIVIDUALLY TO LEFT ANTERIOR DESCENDING ARTERY AND LEFT CIRCUMFLEX ARTERY (DUAL OSTIA). THE SUBJECT WAS TREATED WITH HEPARIN DRIP DUE TO THE MI AND ASPIRIN ATORVASTATIN WERE CONTINUED DUE TO MECHANICAL OBSTRUCTION OF CORONARY SINUSES BY THE LOTUS EDGE VALVE. ON (B)(6) 2020, THE MYOCARDIAL INFARCTION WAS CONSIDERED RECOVERED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND OTHER COAGULANTS.

    Description of Event or Problem · 1

    (B)(6) POST MARKET STUDY. IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, HEPARIN OR ANOTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS NOT ON A REGIMEN OF ASPIRIN OR ANTIPLATELET MEDICATION OTHER THAN ASPIRIN AT THE TIME OF THE INDEX PROCEDURE. A LOTUS INTRODUCER SHEATH(LIS) WAS PLACED AND THEN THE NATIVE AORTIC VALVE WAS TREATED WITH BALLOON AORTIC VALVULOPLASTY(BAV), ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). OF NOTE, A NEW CONDUCTION DISTURBANCE (LEFT BUNDLE BRANCH BLOCK) WAS NOTED POST BAV. A 27 MM LOTUS EDGE VALVE WAS THEN INSERTED, HOWEVER WAS NOT-IMPLANTED SINCE THE VALVE WAS OVER-SIZED. THE 27 MM LOTUS EDGE VALVE WAS RETRIEVED AND EXCHANGED FOR A 25 MM LOTUS EDGE VALVE WHICH WAS DEPLOYED SUCCESSFULLY INTO THE PROPER ANATOMICAL LOCATION. TWO DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND OTHER ANTICOAGULANTS. POST PROCEDURE EVENT SUMMARY: ON (B)(6) 2020, 453 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH LEFT MAIN CORONARY OBSTRUCTION BY THE NATIVE LEFT LEAFLET. COMPUTERIZED TOMOGRAPHY (CT) SCAN, ECHOCARDIOGRAM, AND LAB TESTS WERE PERFORMED AS THE DIAGNOSTIC PROCEDURES. THE SUBJECT WAS HOSPITALIZED FOR THE EVENTS AND THE 25 MM LOTUS EDGE VALVE WAS EXPLANTED AND REPLACED WITH NON-BOSTON SCIENTIFIC (BSC) VALVE WITH AORTIC ROOT ENLARGEMENT. THE EVENT WAS CONSIDERED RECOVERED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419752 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0022984934

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention