BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 10945904 · Received December 4, 2020

    Report

    Report Number
    2134265-2020-16828
    Event Type
    Injury
    Date Received
    December 4, 2020
    Date of Event
    September 4, 2020
    Report Date
    March 1, 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
    OH, 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. H6 IMPACT CODES - UPDATED.

    Description of Event or Problem · 0

    REPRISE IV STUDY: IT WAS REPORTED THAT PARAVALVULAR REGURGITATION OCCURRED. THE PATIENT WAS ENROLLED INTO THE REPRISE IV STUDY IN JANUARY 2020 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 ANTIPLATELET MEDICATIONS OR ASPIRIN. A LOADING DOSE OF 324 MG OF ASPIRIN AND 75 MG OF CLOPIDOGREL WERE GIVEN THE DAY OF THE PROCEDURE. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH 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). ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON CLOPIDOGREL AND OTHER ANTICOAGULANT MEDICATIONS. IN (B)(6) 2020, 218 DAYS POST INDEX PROCEDURE, THE ECHOCARDIOGRAM REVEALED WORSENING MODERATE PARAVALVULAR AORTIC VALVE REGURGITATION. NO ACTION WAS TAKEN. IT WAS FURTHER REPORTED THAT IN (B)(6) 2020, WORSENING AORTIC VALVE REGURGITATION WAS AGAIN NOTED. IN (B)(6) 2020, 292 DAYS POST INDEX PROCEDURE, A REPEAT ECHOCARDIOGRAM WAS PERFORMED AND REVEALED WORSENING AORTIC PARAVALVULAR REGURGITATION LOCATED AT THE MID PORTION OF THE LEFT CUSP WITH THE CAVITY SIZE MILDLY DILATED, SYSTOLIC FUNCTION WAS SEVERELY REDUCED, THE LEFT VENTRICULAR EJECTION FRACTION 20 TO 25%, SEVERE DIFFUSE HYPOKINESIS AND A MEAN AORTIC PRESSURE GRADIENT OF 9 MM HG. DIAGNOSTIC CATHETERIZATION AND LAB TESTS WERE PERFORMED AS A DIAGNOSTIC PROCEDURE. THE EVENT WAS TREATED MEDICALLY AND AN ATTEMPT WAS MADE AT PERCUTANEOUS PLUGGING TO REPAIR THE PARAVALVULAR REGURGITATION. MULTIPLE FULL ATTEMPTS WERE MADE TO PASS A WIRE THROUGH THE REGURGITATION AREA, BUT WAS UNSUCCESSFUL, SO THE PROCEDURE WAS TERMINATED. THE PATIENT ALSO HAD UNRELATED HEART FAILURE, SO THE PROCEDURE WAS FOLLOWED BY A RIGHT HEART CATHETERIZATION WHICH SHOWED MARKEDLY ELEVATED FILLING PRESSURES. THE PATIENT WAS ADMITTED TO THE HEART FAILURE SERVICE FOR DIURESIS AND OPTIMIZATION OF CARDIAC FUNCTION. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED RECOVERED AND THE PATIENT WAS DISCHARGED (B)(6) 2020. IT WAS FURTHER REPORTED THAT IN (B)(6) 2020, THE PATIENT PRESENTED TO THE HOSPITAL FOR RIGHT HEART CATHERIZATION. PHYSICAL EXAMINATION REVEALED +2 EDEMA IN THE EXTREMITIES, JUGULAR VEIN DISTENTION (9 CM), PRESERVED CAROTID UPSTROKE AND NO AUDIBLE BRUITS. THE PATIENT WAS DIAGNOSED WITH ACUTE DECOMPENSATED SYSTOLIC HEART FAILURE AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT; IV LASIX WAS INITIATED WITH FLUID AND SODIUM RESTRICTION. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON ORAL LASIX AND BISOPROLOL. THE SITE CONFIRMED THAT THE HEART FAILURE WAS NOT RELATED TO COVID-19. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS RECOMMENDED TO EVALUATE MITRAL VALVE. THE PATIENT WAS DIAGNOSED WITH NON-RHEUMATIC MITRAL REGURGITATION AND, THE NON-RHEUMATIC MITRAL REGURGITATION WAS TREATED WITH MEDICATIONS. MITRAL CLIP INTERVENTION WAS PLANNED FOR A LATER DATE. THE FOLLOWING DAY, DOBUTAMINE WAS INITIATED FOR LOW CARDIAC OUTPUT AND TO IMPROVE RENAL FUNCTION; HOWEVER, WAS STOPPED THE NEXT DAY DUE TO VARIATIONS IN HEART RATE. IV AMIODARONE WAS THEN INITIATED. IV LASIX WAS DISCONTINUED. THREE DAYS LATER, CARDIAC SURGERY WAS CONSULTED FOR LEFT VENTRICULAR ASSIST DEVICE (LVAD) WORKUP. THE PATIENT, HOWEVER, OPTED FOR MEDICAL MANAGEMENT. ON THE SAME DAY, LIMITED TRANSTHORACIC ECHOCARDIOGRAM ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION REDUCED TO 10-15%. DIGOXIN AND BISOPROLOL WERE ADMINISTERED. IN (B)(6) 2020, 316 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED FOR CLOSURE OF THE KNOWN AORTIC PARAVALVULAR LEAK. DIAGNOSTIC CATHETERIZATION AND LAB TESTS WERE ALSO PERFORMED. AN ATTEMPT WAS MADE TO REPAIR PARAVALVULAR LEAK BY PLUGGING WITH PERCUTANEOUS NON-BOSTON SCIENTIFIC DEVICE. THE PROCEDURE WAS TERMINATED AFTER SEVERAL FAILED ATTEMPTS. ON THE SAME DAY, THE PATIENT DEVELOPED INCREASING SHORTNESS OF BREATH DURING ATTEMPTS TO CLOSE PARAVALVULAR LEAKAGE. PHYSICAL EXAMINATION REVEALED 2+ EDEMA TO THE KNEES AND JUGULAR VEIN DISTENTION. THE PATIENT WAS DIAGNOSED WITH NYHA CLASS III ACUTE ON CHRONIC SYSTOLIC HEART FAILURE AND ELEVATED WEDGE PRESSURE. THE PATIENT WAS TREATED WITH 100 MG IV LASIX AND TORSEMIDE. XARELTO WAS WITHHELD. THE PATIENT WAS DISCHARGED HOME ON TORSEMIDE. IN (B)(6) 2021, 382 DAYS POST INDEX PROCEDURE, THE PATIENT DIED.

    Description of Event or Problem · 0

    REPRISE IV STUDY. IT WAS REPORTED THAT PARAVALVULAR REGURGITATION OCCURRED. THE PATIENT WAS ENROLLED INTO THE REPRISE IV STUDY IN (B)(6) 2020 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 ANTIPLATELET MEDICATIONS OR ASPIRIN. A LOADING DOSE OF 324 MG OF ASPIRIN AND 75 MG OF CLOPIDOGREL WERE GIVEN THE DAY OF THE PROCEDURE. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH 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). ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON CLOPIDOGREL AND OTHER ANTICOAGULANT MEDICATIONS. IN (B)(6) 2020, 218 DAYS POST INDEX PROCEDURE, THE ECHOCARDIOGRAM REVEALED WORSENING MODERATE PARAVALVULAR AORTIC VALVE REGURGITATION. NO ACTION WAS TAKEN. IT WAS FURTHER REPORTED THAT IN (B)(6) 2020, WORSENING AORTIC VALVE REGURGITATION WAS AGAIN NOTED. IN (B)(6) 2020, 292 DAYS POST INDEX PROCEDURE, A REPEAT ECHOCARDIOGRAM WAS PERFORMED AND REVEALED WORSENING AORTIC PARAVALVULAR REGURGITATION LOCATED AT THE MID PORTION OF THE LEFT CUSP WITH THE CAVITY SIZE MILDLY DILATED, SYSTOLIC FUNCTION WAS SEVERELY REDUCED, THE LEFT VENTRICULAR EJECTION FRACTION 20 TO 25%, SEVERE DIFFUSE HYPOKINESIS AND A MEAN AORTIC PRESSURE GRADIENT OF 9 MM HG. DIAGNOSTIC CATHETERIZATION AND LAB TESTS WERE PERFORMED AS A DIAGNOSTIC PROCEDURE. THE EVENT WAS TREATED MEDICALLY AND AN ATTEMPT WAS MADE AT PERCUTANEOUS PLUGGING TO REPAIR THE PARAVALVULAR REGURGITATION. MULTIPLE FULL ATTEMPTS WERE MADE TO PASS A WIRE THROUGH THE REGURGITATION AREA, BUT WAS UNSUCCESSFUL, SO THE PROCEDURE WAS TERMINATED. THE PATIENT ALSO HAD UNRELATED HEART FAILURE, SO THE PROCEDURE WAS FOLLOWED BY A RIGHT HEART CATHETERIZATION WHICH SHOWED MARKEDLY ELEVATED FILLING PRESSURES. THE PATIENT WAS ADMITTED TO THE HEART FAILURE SERVICE FOR DIURESIS AND OPTIMIZATION OF CARDIAC FUNCTION. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED RECOVERED AND THE PATIENT WAS DISCHARGED MID-(B)(6) 2020.

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT MODERATE PARAVALVULAR AORTIC VALVE REGURGITATION OCCURRED. THE PATIENT WAS ENROLLED INTO THE (B)(6) STUDY IN (B)(6) 2020 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 ANTIPLATELET MEDICATIONS OR ASPIRIN. A LOADING DOSE OF 324 MG OF ASPIRIN AND 75 MG OF CLOPIDOGREL WERE GIVEN THE DAY OF THE PROCEDURE. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH 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). ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON CLOPIDOGREL AND OTHER ANTICOAGULANT MEDICATIONS. IN (B)(6) 2020, 218 DAYS POST INDEX PROCEDURE, THE ECHOCARDIOGRAM REVEALED WORSENING MODERATE PARAVALVULAR AORTIC VALVE REGURGITATION. NO ACTION WAS TAKEN. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411683 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0024188503

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| R