BEUDAMED
    FDA Adverse Event Death Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 10763350 · Received October 30, 2020

    Report

    Report Number
    2134265-2020-14329
    Event Type
    Death
    Date Received
    October 30, 2020
    Date of Event
    October 6, 2020
    Report Date
    November 25, 2020
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A2: AGE AT TIME OF EVENT: UPDATED. A3: SEX: UPDATED. B5: DESCRIBE EVENT OR PROBLEM: UPDATED. B7: OTHER RELEVANT HISTORY: UPDATED. H3: DEVICE EVAL BY MANUFACTURER: THE DEVICE WAS NOT RETURNED THEREFORE DEVICE ANALYSIS COULD NOT BE COMPLETED. THE LOTUS EDGE VALVE WAS IMPLANTED, AND THE LOTUS EDGE DELIVERY SYSTEM WAS DISPOSED. PROCEDURAL IMAGING WAS PROVIDED TO ASSIST IN THE INVESTIGATION AND WAS REVIEWED BY A BSC QUALITY ENGINEER. THE PROVIDED MEDIA SHOWS 15 SERIES FROM A TRANSCATHETER AORTIC VALVE IMPLANTATION INTO AN AORTIC ANNULUS. THE LOTUS EDGE VALVE IS BEING VISUALIZED IN THE CORRECT LOCKING VIEW, AS THE BRAID-MARKER IS ON THE EXTREME LEFT (NON-CORONARY CUSP SIDE) OF THE LOTUS EDGE VALVE. IN SERIES 5 AND 6 THE LOTUS EDGE VALVE IS POSITIONED AT THE ANNULUS. SERIES 7 SHOWS THE LOTUS EDGE VALVE UNSHEATHED. IN SERIES 8 AND 9 THE LOTUS EDGE VALVE IS POSITIONED DEEP, AT THE PAUSE BEFORE LOCK ASSESSMENT AS THE BUCKLE AND POSTS ARE SPACED APART. A CONTRAST SHOT IS PERFORMED, AND THE LOTUS EDGE VALVE HAS BEEN PARTIALLY RE-CAPTURED IN SERIES 10. IN SERIES 11 THE LOTUS EDGE VALVE IS UNSHEATHED AT A HIGHER POSITION. IN SERIES 12, THE LOTUS EDGE VALVE IS VISUALIZED FROM ANOTHER ANGLE, RIGHT ANTERIOR OBLIQUE (RAO). THE LOTUS EDGE VALVE IS PLACED HIGHER AND IN SERIES 14 IT IS LOCKED WITH A VISIBLE WAIST WHILE BEING VISUALIZED IN THE CORRECT LOCKING VIEW. THE LOTUS EDGE VALVE NOSECONE AND COILED TIP OF THE SAFARI2 GUIDEWIRE APPEAR DEEPER WHEN COMPARING THE EARLIER SERIES (4-6) AND THE SUBSEQUENT SERIES WHERE THE LOTUS EDGE VALVE HAS BEEN UN-SHEATHED, SUGGESTING THAT THERE WAS SUB-OPTIMAL GUIDEWIRE MANAGEMENT DURING THE PROCEDURE. THERE ARE NO SERIES SHOWING THE RELEASED LOTUS EDGE VALVE. THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE MEDIA PROVIDED, AS IT WAS REPORTED AS OCCURRING POST-IMPLANT AND THE MEDIA REVIEWED HAS NOT CAPTURED THIS. IT WAS REPORTED THAT 4 PARTIAL RE-SHEATHS AND ONE FULL RE-SHEATH WERE PERFORMED, HOWEVER THESE HAVE NOT BEEN CAPTURED IN THE PROCEDURAL RECORDINGS PROVIDED. THE XS SAFARI2 GUIDEWIRE IS DEEP WITHIN THE VENTRICLE, CURVED SHARPLY UPWARDS INDICATING DIRECT CONTACT WITH THE APEX WALL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN APEX RUPTURE, HYPOTENSION, MAJOR BLEEDING, AND DEATH OCCURRED. A 23MM LOTUS EDGE VALVE AND SAFARI2 GUIDEWIRE WERE CHOSEN FOR USE IN A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. A PRE-DILATATION WAS PERFORMED WITH A 20MM NON-BSC BALLOON CATHETER ON THE SEVERELY CALCIFIED, 21MM IN DIAMETER, AORTIC VALVE ANNULUS. THE 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED AFTER FOUR PARTIAL RESHEATHS AND ONE FULL RESHEATH WERE PERFORMED. THERE WAS NO PARAVALVULAR LEAK PRESENT. DURING WITHDRAWAL OF THE SAFARI2 GUIDEWIRE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ANGIOGRAPHY IDENTIFIED AN APEX RUPTURE. SURGICAL INTERVENTION WAS PERFORMED. THE NIGHT AFTER THE PROCEDURE THE PATIENT PASSED AWAY. THE SUTURING OF THE LESION WAS INITIALLY SUCCESSFUL; HOWEVER LATER THE PATIENT DEVELOPED A DIFFUSE BLEEDING PROBLEM AND LIKELY DIED OF A TYPE OF SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS). IT WAS FURTHER REPORTED THAT THE PATIENT'S LEFT VENTRICLE WAS HYPERTROPHIC. THE PREVIOUSLY REPORTED SURGICAL PROCEDURE WAS CARRIED OUT AS A LAST RESORT. THE PATIENT WAS UNDER MECHANICAL AND MEDICAL RESUSCITATION. AN EMERGENCY THORACOTOMY WAS PERFORMED VIA A MEDIAN STERNOTOMY. HEPARIN WAS ADMINISTERED. AFTER SUCTIONING OFF THE BLOODY EFFUSION, ACTIVE BLEEDING APPEARED FROM A TEAR IN THE AREA OF THE ANTERIOR WALL OF THE HEART. AFTER MANUAL COMPRESSION, THE BLEEDING WAS STOPPED. THE LESION WAS TREATED WITH A FELT-REINFORCED 3-0 PROLENE SUTURE. THEN CANNULATION OF THE ASCENDING AORTA AND THE RIGHT ATRIUM WAS COMPLETED. EXTRA CORPOREAL CIRCULATION (EKZ) WAS INITIATED. CLAMPING OF THE ASCENDING AORTA AND PERFUSION OF THE HEART THROUGH AN AORTIC ROOT CANNULA WAS PERFORMED. THERE WAS A 3 CM LINEAR TEAR IN THE LEFT VENTRICLE IMMEDIATELY TO THE LEFT OF THE COURSE OF THE LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS TREATED WITH TWO (2) ROWS OF 3-0 PROLENE SUTURES ON TEFLON FELT STRIPS WAS COMPLETED. EKZ WAS DISCONTINUED WITH STABLE CIRCULATORY CONDITIONS. NO SIGNIFICANT LEAKAGE WAS NOTED. A TRANSTHORACIC ECHOCARDIOGRAM(TEE) PERFORMED INTRAOPERATIVELY SHOWED GOOD LEFT VENTRICULAR FUNCTION. THE THORAX WAS CLOSED IN LAYERS AFTER TWO DRAINS HAVE BEEN INSERTED PERICARDIALLY AND SUBSTERNAL AS WELL AS PLEURAL DRAINAGE INSERT LEFT AND RIGHT USING STERILE BANDAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN APEX RUPTURE, HYPOTENSION, MAJOR BLEEDING, AND DEATH OCCURRED. A 23MM LOTUS EDGE VALVE AND SAFARI2 GUIDEWIRE WERE CHOSEN FOR USE IN A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. A PRE-DILATATION WAS PERFORMED WITH A 20MM NON-BSC BALLOON CATHETER ON THE SEVERELY CALCIFIED, 21MM IN DIAMETER, AORTIC VALVE ANNULUS. THE 23MM LOTUS EDGE VALVE WAS SUCCESSFULLY IMPLANTED AFTER FOUR PARTIAL RESHEATHS AND ONE FULL RESHEATH WERE PERFORMED. THERE WAS NO PARAVALVULAR LEAK PRESENT. DURING WITHDRAWAL OF THE SAFARI2 GUIDEWIRE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ANGIOGRAPHY IDENTIFIED AN APEX RUPTURE. SURGICAL INTERVENTION WAS PERFORMED. THE NIGHT AFTER THE PROCEDURE THE PATIENT PASSED AWAY. THE SUTURING OF THE LESION WAS INITIALLY SUCCESSFUL; HOWEVER LATER THE PATIENT DEVELOPED A DIFFUSE BLEEDING PROBLEM AND LIKELY DIED OF A TYPE OF SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229209 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10394 0025668785

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R