BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN® ACCESS SYSTEM

    MDR report key: 6177908 · Received December 15, 2016

    Report

    Report Number
    2134265-2016-11109
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    December 30, 2014
    Report Date
    November 16, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT A GROIN HEMATOMA OCCURRED POST PROCEDURE RESULTING IN ADDITIONAL COMPLICATIONS AND THE PATIENT ULTIMATELY EXPIRED. THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE IN (B)(6) 2014. USING A TRANSFEMORAL APPROACH ON THE RIGHT SIDE, THE WATCHMAN ACCESS SYSTEM WAS POSITIONED IN THE LAA AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS ADVANCED AND DEPLOYED. ONE PARTIAL RECAPTURE WAS PERFORMED DUE TO POSITION. THE CLOSURE DEVICE WAS RE-POSITIONED AND RELEASED. A COMPLETE SEAL WAS NOTED AND THE DEVICE WAS PLACED DISTAL TO AND SPANNED THE ENTIRE LAA OSTIUM. FOURTEEN DAYS POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL; A PRONOUNCED SWELLING WAS FOUND IN THE RIGHT GROIN, AS WELL AS INCIPIENT CIRCULATORY INSTABILITY. IMMEDIATELY AFTER THE PATIENT¿S ADMISSION, AN EMERGENCY SURGICAL TREATMENT WAS PERFORMED FOR THE SUTURE OF THE FEMORAL ARTERY AND THE REMOVAL OF THE HEMATOMA. HOWEVER, DESPITE THE INLYING DRAINAGE, A NEW SWELLING DEVELOPED SHORTLY AFTERWARDS IN THE RIGHT GROIN. THREE DAYS LATER, A SURGICAL REVISION FOR THE REMOVAL OF THE HEMATOMA AND THE PLACEMENT OF THE DRAINAGE WAS REQUIRED. THE SWELLING LED TO THE DEVELOPMENT OF SUPERFICIAL SKIN NECROSIS ON THE PROXIMAL MEDIAL THIGHS, WHICH GRADUALLY SHOWED SIGNS OF NONIRRITATING HEALING DUE TO REGULAR BANDAGE CHANGE. THE POSTOPERATIVE PROGRESS WAS IMPEDED BY A MASSIVE RIGHT-SIDED RETROPERITONEAL HEMATOMA, WHICH COULD, HOWEVER, BE HANDLED BY MEANS OF CONSERVATIVE TREATMENT. BY KNOWN COMPENSATED RENAL FAILURE, GIVEN THE ANTIBIOTIC-INDUCED ACUTE KIDNEY INJURY FROM THE PREVIOUS SPRING A NEW ACUTE KIDNEY INJURY WITH TEMPORARY REQUIREMENT OF DIALYSIS OCCURRED. A NEW MEDICAL TREATMENT LED TO RECOMPENSATION OF THE URINARY RETENTION VALUES. AT ADMISSION TO THE HOSPITAL, THE INITIALLY COLLECTED SAMPLES FROM THE NOSE AND THROAT REGION WERE ALREADY INFESTED WITH (B)(6). A (B)(6) PNEUMONIA REQUIRING LONG-TERM VENTILATION DEVELOPED PERI-PROCEDURALLY. TO ENSURE VENTILATION ACCESS, A DILATATIONAL TRACHEOSTOMY WAS PERFORMED. AFTER SUCCESSFUL WEANING, THE PATIENT COULD FINALLY BE TRANSFERRED TO THE GENERAL WARD APPROXIMATELY 5 WEEKS POST PROCEDURE. HOWEVER, HIS ALREADY POOR GENERAL STATE KEPT DETERIORATING. THE PATIENT EXPIRED 11 DAYS AFTER TRANSFER TO THE GENERAL WARD, SHOWING SIGNS OF TERMINAL CIRCULATORY COLLAPSE. THE RESUSCITATIVE MEASURES WERE WITHHELD BASED ON FAMILY AGREEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829877 WATCHMAN® ACCESS SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635TS20060 16900812

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R