BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE

    MDR report key: 9274181 · Received November 4, 2019

    Report

    Report Number
    2134265-2019-13200
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    October 10, 2019
    Report Date
    June 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    UDI-DI
    08714729960911
    PMA / PMN Number
    P180029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: MEDIA REVIEW: THE VALVE REMAINS IN USE. THE DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS. A 16-SECOND MOVIE CLIP OF THE PROCEDURE WAS REVIEWED BY A BSC QUALITY ENGINEER. THE 16 SECOND .MOV FILE SHOWS AN OVER-SHEATHED LOTUS EDGE VALVE SYSTEM(LEVS) PASS THROUGH THE AORTIC ANNULUS ON THE 2ND ATTEMPT. THE OUTLINE OF THE ACTUAL CARDIAC VASCULATURE OF THE PATIENT CANNOT BE SEEN FROM THE AVAILABLE MEDIA. HOWEVER, FROM THE SHAPE OF THE LEVS DURING THE 16-SECOND .MOV CLIP, IT CAN BE SURMISED THAT THE ANGLE OF THE AORTIC ARCH APPEARS ACUTE AND THE ANGLE OF THE AORTIC ANNULUS APPEARS GREATER THAN 70 DEGREES TO THE HORIZONTAL, WHICH IS CONSISTENT WITH THE CHALLENGING ANATOMY REPORTED BY THE PHYSICIAN. THE LEVS CROSSES THROUGH THE AORTIC ANNULUS ON THE SECOND ATTEMPT, WHICH IS CONSISTENT WITH THE REPORTED UNUSUAL AMOUNT OF FORCE REQUIRED TO CROSS THE AORTIC ANNULUS. THE CAUSE, LOCATION AND TIMEPOINT OF PERICARDIAL EFFUSION CANNOT BE DETERMINED FROM THIS 16 SECOND .MOV CLIP.

    Additional Manufacturer Narrative · 0

    MEDIA REVIEW: THE VALVE REMAINS IN USE. THE DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS. A 16-SECOND MOVIE CLIP OF THE PROCEDURE WAS REVIEWED BY A BSC QUALITY ENGINEER. THE 16 SECOND .MOV FILE SHOWS AN OVER-SHEATHED LOTUS EDGE VALVE SYSTEM(LEVS) PASS THROUGH THE AORTIC ANNULUS ON THE 2ND ATTEMPT. THE OUTLINE OF THE ACTUAL CARDIAC VASCULATURE OF THE PATIENT CANNOT BE SEEN FROM THE AVAILABLE MEDIA. HOWEVER, FROM THE SHAPE OF THE LEVS DURING THE 16-SECOND .MOV CLIP, IT CAN BE SURMISED THAT THE ANGLE OF THE AORTIC ARCH APPEARS ACUTE AND THE ANGLE OF THE AORTIC ANNULUS APPEARS GREATER THAN 70 DEGREES TO THE HORIZONTAL, WHICH IS CONSISTENT WITH THE CHALLENGING ANATOMY REPORTED BY THE PHYSICIAN. THE LEVS CROSSES THROUGH THE AORTIC ANNULUS ON THE SECOND ATTEMPT, WHICH IS CONSISTENT WITH THE REPORTED UNUSUAL AMOUNT OF FORCE REQUIRED TO CROSS THE AORTIC ANNULUS. THE CAUSE, LOCATION AND TIMEPOINT OF PERICARDIAL EFFUSION CANNOT BE DETERMINED FROM THIS 16 SECOND .MOV CLIP. B5 DESCRIBE EVENT OR PROBLEM: UPDATED D2 COMMON DEVICE NAME CORRECTED FROM LOTUS EDGE TM VALVE SYSTEM 23 MM TO LOTUS EDGE TM VALVE SYSTEM 25 MM F10 PATIENT CODES - UPDATED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARDIAC TAMPONADE OCCURRED. THE PATIENT PRESENTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 25MM LOTUS EDGE VALVE. THERE WAS SOME CHALLENGING PATIENT ANATOMY (THE NOSE-CONE WAS BIASED TOWARDS NON-CORONARY CUSP RATHER THAN CENTRALIZED TO THE VALVE) THAT CAUSED THE PHYSICIAN TO APPLY AN UNUSUAL AMOUNT OF PRESSURE TO CROSS THE VALVE WITH THE LOTUS EDGE DEVICE. AFTER DEPLOYING THE VALVE, AND PRIOR TO RELEASE STAGE 1, AN EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE EFFUSION LED TO TAMPONADE, WHICH REQUIRED SURGICAL IMPLANT OF A PERICARDIAL DRAIN. THE CAUSE OF THE EFFUSION WAS UNCLEAR TO THE PHYSICIANS, AND THE SUSPECTED LOCATION WAS THE LEFT VENTRICLE. THE PATIENT WAS INTUBATED AND TAKEN TO INTENSIVE CARE UNIT (ICU). THE PATIENT WAS ON THE TELEMETRY UNIT AT THE HEALTHCARE FACILITY 13 DAYS POST INDEX PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARDIAC TAMPONADE OCCURRED. THE PATIENT PRESENTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 25MM LOTUS EDGE VALVE. THERE WAS SOME CHALLENGING PATIENT ANATOMY (THE NOSE-CONE WAS BIASED TOWARDS NON-CORONARY CUSP RATHER THAN CENTRALIZED TO THE VALVE) THAT CAUSED THE PHYSICIAN TO APPLY AN UNUSUAL AMOUNT OF PRESSURE TO CROSS THE NATIVE VALVE WITH THE LOTUS EDGE DEVICE. AFTER DEPLOYING THE VALVE, AND PRIOR TO RELEASE STAGE 1, AN EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE EFFUSION LED TO TAMPONADE, WHICH REQUIRED SURGICAL IMPLANT OF A PERICARDIAL DRAIN. THE CAUSE OF THE EFFUSION WAS UNCLEAR TO THE PHYSICIANS, AND THE SUSPECTED LOCATION WAS THE LEFT VENTRICLE. THE PATIENT WAS INTUBATED AND TAKEN TO INTENSIVE CARE UNIT (ICU). THE PATIENT WAS ON THE TELEMETRY UNIT AT THE HEALTHCARE FACILITY 13 DAYS POST INDEX PROCEDURE. IT WAS FURTHER REPORTED THAT CARDIAC ARREST AND BLOOD LOSS OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARDIAC TAMPONADE OCCURRED. THE PATIENT PRESENTED FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WITH A 25MM LOTUS EDGE VALVE. THERE WAS SOME CHALLENGING PATIENT ANATOMY (THE NOSE-CONE WAS BIASED TOWARDS NON-CORONARY CUSP RATHER THAN CENTRALIZED TO THE VALVE) THAT CAUSED THE PHYSICIAN TO APPLY AN UNUSUAL AMOUNT OF PRESSURE TO CROSS THE VALVE WITH THE LOTUS EDGE DEVICE. AFTER DEPLOYING THE VALVE, AND PRIOR TO RELEASE STAGE 1, AN EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE EFFUSION LED TO TAMPONADE, WHICH REQUIRED SURGICAL IMPLANT OF A PERICARDIAL DRAIN. THE CAUSE OF THE EFFUSION WAS UNCLEAR TO THE PHYSICIANS, AND THE SUSPECTED LOCATION WAS THE LEFT VENTRICLE. THE PATIENT WAS INTUBATED AND TAKEN TO INTENSIVE CARE UNIT (ICU). THE PATIENT WAS ON THE TELEMETRY UNIT AT THE HEALTHCARE FACILITY 13 DAYS POST INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067038 LOTUS EDGE VALVE LOTUS EDGE TM VALVE SYSTEM 25 MM NPT BOSTON SCIENTIFIC CORPORATION H749LVSUS250 0023759594 08714729960911

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention