BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 10553363 · Received September 18, 2020

    Report

    Report Number
    2134265-2020-12803
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    March 6, 2020
    Report Date
    February 16, 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.

    Description of Event or Problem · 0

    REPRISE IV STUDY. IT WAS REPORTED THAT MYOCARDIAL TRAUMA AND MITRAL REGURGITATION 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 ON A PRIOR REGIMEN OF ASPIRIN. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 23 MM LOTUS EDGE VALVE. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2020, 203 DAYS POST INDEX PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN AND ECHOCARDIOGRAM REVEALED SEVERE MITRAL REGURGITATION WITH RUPTURE OF THE PRIMARY CHORDA. IN (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION. THE MITRAL VALVE AND PRIMARY CHORDA WERE THEN SURGICALLY REPAIRED. THAT DAY, THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE REPAIR ON ASPIRIN AND TICAGRELOR. IT WAS FURTHER REPORTED THAT IN (B)(6) 2020, 203 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A STENT IMPLANTATION. THE PREVIOUSLY REPORTED ECHOCARDIOGRAM ALSO REVEALED SEVERE FLAIL OF THE ANTERIOR LEAFLET. AT THAT TIME, THE PATIENT ALSO REPORTED TO HAVE MODERATE SHORTNESS OF BREATH WHILE WALKING ABOUT A HALF BLOCK AND DYSPNEA WITH CLIMBING ONE FLIGHT OF STAIRS. ELEVEN DAYS AFTER THIS EVENT, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION. THE MITRAL VALVE AND PRIMARY CHORDA WERE THEN SURGICALLY REPAIRED. IN (B)(6) 2020, ALMOST ONE MONTH AFTER THE REPAIR, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. THE EVENT WAS CONSIDERED RECOVERED IN (B)(6) 2020. IT WAS FURTHER REPORTED THAT THE PATIENT INITIALLY PRESENTED WITH CHEST PAIN 203 DAYS POST INDEX PROCEDURE. THEN, 214 DAYS POST INDEX PROCEDURE, WAS WHEN THE PATIENT REPORTED MODERATE SHORTNESS OF BREATH WHILE WALKING ABOUT A HALF A BLOCK AND DYSPNEA WITH CLIMBING ONE FLIGHT OF STAIRS. THE PATIENT HAD BEEN FOLLOWING A LOW SODIUM DIET AND WAS ON PRN LASIX 3 TIMES PER DAY. THE PATIENT WAS HOSPITALIZED FOR FURTHER HOSPITALIZATION AT THAT TIME. CT SCAN, DIAGNOSTIC CATHETERIZATION, ECHOCARDIOGRAM, EXERCISE STRESS TEST AND LAB TESTS WERE PERFORMED AS DIAGNOSTIC TESTS.

    Description of Event or Problem · 0

    REPRISE IV STUDY. IT WAS REPORTED THAT MYOCARDIAL TRAUMA AND MITRAL REGURGITATION 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 ON A PRIOR REGIMEN OF ASPIRIN. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 23 MM LOTUS EDGE VALVE. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2020, 203 DAYS POST INDEX PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN AND ECHOCARDIOGRAM REVEALED SEVERE MITRAL REGURGITATION WITH RUPTURE OF THE PRIMARY CHORDA. IN (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION. THE MITRAL VALVE AND PRIMARY CHORDA WERE THEN SURGICALLY REPAIRED. THAT DAY, THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE REPAIR ON ASPIRIN AND TICAGRELOR. IT WAS FURTHER REPORTED THAT IN (B)(6) 2020, 203 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A STENT IMPLANTATION. THE PREVIOUSLY REPORTED ECHOCARDIOGRAM ALSO REVEALED SEVERE FLAIL OF THE ANTERIOR LEAFLET. AT THAT TIME, THE PATIENT ALSO REPORTED TO HAVE MODERATE SHORTNESS OF BREATH WHILE WALKING ABOUT A HALF BLOCK AND DYSPNEA WITH CLIMBING ONE FLIGHT OF STAIRS. ELEVEN DAYS AFTER THIS EVENT, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION. THE MITRAL VALVE AND PRIMARY CHORDA WERE THEN SURGICALLY REPAIRED. IN (B)(6) 2020, ALMOST ONE MONTH AFTER THE REPAIR, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. THE EVENT WAS CONSIDERED RECOVERED IN (B)(6) 2020.

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT MYOCARDIAL TRAUMA AND MITRAL REGURGITATION 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 ON A PRIOR REGIMEN OF ASPIRIN. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 23 MM LOTUS EDGE VALVE. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2020, 203 DAYS POST INDEX PROCEDURE, A COMPUTED TOMOGRAPHY (CT) SCAN AND ECHOCARDIOGRAM REVEALED SEVERE MITRAL REGURGITATION WITH RUPTURE OF THE PRIMARY CHORDA. IN (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION. THE MITRAL VALVE AND PRIMARY CHORDA WERE THEN SURGICALLY REPAIRED. THAT DAY, THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED ONE DAY AFTER THE REPAIR ON ASPIRIN AND TICAGRELOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018911 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0022984575

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R