BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 5053373 · Received September 3, 2015

    Report

    Report Number
    2134265-2015-05824
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 6, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF THE WATCHMAN DELIVERY SYSTEM (WDS) AND THE WATCHMAN ACCESS SHEATH (WAS) FOR THE RELATED COMPLAINT. THE WDS WAS RECEIVED INSIDE THE SHAFT OF THE WAS. THERE WAS BLOOD ON AND IN THE SHAFT AND ON THE IMPLANT. THE SHAFT WAS KINKED AT THE HUB OF THE WDS. THE IMPLANT WAS RECEIVED IN THE DEPLOYED STATE. SOME OF THE ANCHORS WERE BENT AND DAMAGED. THE IMPLANT WAS REMOVED FROM THE WDS AND THE WDS WAS REMOVED FROM THE SHAFT OF THE WAS WITH NO RESISTANCE. THERE WAS NO DAMAGE OR IRREGULARITIES TO THE COREWIRE. THERE WAS NO DAMAGE OR IRREGULARITIES TO THE TIP. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2015-05823. IT WAS REPORTED THAT CARDIAC TAMPONADE, PERICARDIAL EFFUSION, AND DEATH OCCURRED. THE PATIENT WAS UNDERGOING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WITH A DOUBLE CURVE WATCHMAN ACCESS SYSTEM AND A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM IN (B)(6) 2015. DUE TO THE LESION IN THE ATRIAL SEPTUM, THE PHYSICIAN PUNCTURED THE ATRIAL SEPTUM IN A VERY HIGH POSITION. THIS RESULTED IN PRESSURE TO THE ANTERIOR WALL OF THE LEFT ATRIUM WHEN THE WATCHMAN ACCESS SYSTEM WAS ADVANCED INTO THE LEFT ATRIUM GUIDED BY THE PIG-TAIL CATHETER. WHEN THE 30MM WATCHMAN CLOSURE DEVICE WAS DEPLOYED, THE TIP OF THE DEVICE CUT THROUGH THE LEFT ATRIUM WHICH LED TO PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. IT WAS NOTED THAT THE 30MM SIZE WAS TOO LARGE FOR THE ANATOMY OF THE LEFT ATRIAL APPENDAGE (LAA) AND THAT THE IMPLANT WAS POSITIONED TOO DEEP. LIGATION OF THE LAA WAS SURGICALLY PERFORMED. THE PATIENT WAS NOT STABLE AND WAS IN OBSERVATION. TWO DAYS LATER, THE PATIENT DIED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2015-05823. IT WAS REPORTED THAT CARDIAC TAMPONADE, PERICARDIAL EFFUSION, AND DEATH OCCURRED. THE PATIENT WAS UNDERGOING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WITH A DOUBLE CURVE WATCHMAN ACCESS SYSTEM AND A 30MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM IN (B)(6) 2015. DUE TO THE LESION IN THE ATRIAL SEPTUM, THE PHYSICIAN PUNCTURED THE ATRIAL SEPTUM IN A VERY HIGH POSITION. THIS RESULTED IN PRESSURE TO THE ANTERIOR WALL OF THE LEFT ATRIUM WHEN THE WATCHMAN ACCESS SYSTEM WAS ADVANCED INTO THE LEFT ATRIUM GUIDED BY THE PIG-TAIL CATHETER. WHEN THE 30MM WATCHMAN CLOSURE DEVICE WAS DEPLOYED, THE TIP OF THE DEVICE CUT THROUGH THE LEFT ATRIUM WHICH LED TO PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. IT WAS NOTED THAT THE 30MM SIZE WAS TOO LARGE FOR THE ANATOMY OF THE LEFT ATRIAL APPENDAGE (LAA) AND THAT THE IMPLANT WAS POSITIONED TOO DEEP. LIGATION OF THE LAA WAS SURGICALLY PERFORMED. THE PATIENT WAS NOT STABLE AND WAS IN OBSERVATION. TWO DAYS LATER, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584470 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WC30060 17484721

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R