BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1702213 · Received May 28, 2010

    Report

    Report Number
    2134265-2010-02507
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K992510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    SAME CASE AS MFG. # 2134265-2010-02375. IT WAS REPORTED THAT POST A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND ENDOSCOPIC ULTRASOUND (EUS) WITH NEUROLYSIS AND ESOPHAGOGASTRODUODENOSCOPY (EGD), A PATIENT DEATH OCCURRED. THE PATIENT HAD COMMON BILE DUCT (CBD) STRICTURE AND DUODENAL STRICTURE. ERCP WAS SCHEDULED TO BE PERFORMED, HOWEVER THE CBD WAS UNABLE TO BE ACCESSED. THE PATIENT WAS REFERRED TO RADIOLOGY AND THE FOLLOWING DAY, A 10X42X75/ 7F UNISTEP PLUS STENT WAS SUCCESSFULLY IMPLANTED IN THE PATIENT'S AMPULLA. THE PATIENT THEN UNDERWENT EUS WITH NEUROLYSIS FOLLOWED BY EGD, AND DUODENAL STENT PLACEMENT TO RELIEVE PAIN. A WALLFLEX ENTERAL DUODENAL STENT WAS SUCCESSFULLY IMPLANTED TO TREAT THE DUODENAL STRICTURE AND BRIDGED THE PAPILLA AND PYLORIS. THE STENT WAS ATTEMPTED TO BE REPOSITIONED BY PULLING IT BACK TOWARDS THE STOMACH WITH FORCEPS. A VESSEL WAS RUPTURED AND A POSSIBLE PULMONARY EMBOLUS AND/OR A POSSIBLE AIR EMBOLUS WAS REPORTED. AN AIR BLOCK TO THE HEART WAS CONFIRMED ON CT. THE PATIENT RECOVERED AND WAS SENT TO THE MICU. THE PATIENT EXPIRED THAT NIGHT. THE PATIENT'S CAUSE OF DEATH WAS REPORTED AS A RESULT OF A RUPTURE OF THE DUODENAL VARICE WHICH CAUSED AN AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M001711340

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death