BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6138185 · Received December 1, 2016

    Report

    Report Number
    2134265-2016-10863
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    UDI-DI
    08714729838234
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-10864. IT WAS REPORTED THAT A PERFORATION WITH SUBSEQUENT PERICARDIAL EFFUSION AND TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN® ACCESS SYSTEM WAS USED WITH A 24MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM. PRIOR TO THE DEVICE BEING IMPLANTED, THE LAA WAS PERFORATED RESULTING IN PERICARDIAL EFFUSION WITH TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND A LITER OF BLOOD WAS DRAINED. THE PATIENT UNDERWENT SURGERY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL POST-SURGERY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PERFORATION OCCURRED PRIOR TO THE CLOSURE DEVICE BEING DEPLOYED. THE WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WAS BEING ADVANCED WITH CONTRAST AND IT WAS SEEN THAT THE CONTRAST WAS FILLING THE PERICARDIAL SPACE. THE PHYSICIAN DECIDED TO PROCEED AND DEPLOY THE CLOSURE DEVICE TO SLOW THE EFFUSION. THE DEVICE WAS RELEASED AND THE WATCHMAN® ACCESS SYSTEM AND CORE WIRE WERE PULLED BACK TO THE RIGHT SIDE OF THE HEART WHEN PROTAMINE WAS ADMINISTERED. DURING SURGERY, THE CLOSURE DEVICE WAS REMOVED AND THE SURGEON PLACED A CLIP ON THE LAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789123 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WU24060 19578453 08714729838234

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention