BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 5674998 · Received May 24, 2016

    Report

    Report Number
    2134265-2016-04335
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    April 26, 2016
    Report Date
    April 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPN-SEARCH CORRECTED FROM UNK727 - WATCHMAN DELIVERY SYSTEM - (INTERVENT CARDIO) - 60000 TO M635WU27060 - FG WATCHMAN LAA CLOSURE DEVICE, 27MM, US - WU2706. UPN CORRECTED FROM UNK727 TO M635WU27060. PMA# OR 510K# CORRECTED FROM M110009 TO P130013. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THEY HAD TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGES TO REVIEW PRIOR TO THE CASE WHICH SHOWED THAT THE LAA ANATOMY WAS SUITABLE FOR A WATCHMAN ® LAA CLOSURE DEVICE. THE TRANSEPTAL PUNCTURE WAS DIFFICULT BECAUSE OF INSTABILITY OF THE NEEDLE ON ATRIAL SEPTUM. THE PATIENT HAD AN ATRIAL SEPTAL ANEURYSM THAT MADE THE ¿MID TO LOW AND POSTERIOR¿ PUNCTURE MORE DIFFICULT. THE MEDICAL TEAM WERE ABLE TO DO A SUCCESSFUL TRANSEPTAL PUNCTURE, BUT ON SHORT AXIS THEY COULD SEE THAT IT WAS QUITE POSTERIOR, VERY CLOSE TO LA WALL. THEY WERE VERY CAREFUL THROUGHOUT THAT STEP. ONCE THAT WAS DONE, THE CASE WAS STRAIGHT FORWARD. THERE WAS ONLY ONE DEPLOYMENT, NO RECAPTURES AND THE CLOSURE DEVICE WAS RELEASED. THE PATIENT PASSED THE RELEASE CRITERIA WITH SUCCESS AND DEVICE SHOWED COMPRESSION OF 30%.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-04373. IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED USING A WATCHMAN ACCESS SYSTEM. THE PHYSICIAN NOTED THERE WAS DIFFICULTY WITH THE TRANSEPTAL CROSSING. ABOUT 4-6 HOURS AFTER THE PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THEY PERFORMED A PERICARDIOCENTESIS TO DRAIN THE FLUID. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS THROMBUS ON THE TRANSSEPTAL SHEATH IN THE RIGHT ATRIUM BEFORE THE TRANSSEPTAL PUNCTURE WAS DONE. IT WAS ASPIRATED THROUGH THE TRANSSEPTAL SHEATH AND THEN THEY PROCEEDED WITH THE TRANSSEPTAL PUNCTURE AND THE OTHER STEPS. THE WAS NOT IN PLACE AT THE TIME. THE PATIENT WAS IN SINUS RHYTHM AT THE TIME OF THE IMPLANT. THE LEFT ATRIUM PRESSURE WAS 13MMHG. HEPARIN WAS INFUSED AND HER ACTIVATED CLOTTING TIME WAS BETWEEN 348 AND 369. FOLLOWING THE RELEASE OF THE DEVICE, THERE WAS A COMPLETE SEAL NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331723 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WU27060 18682234

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention