BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 1930827 · Received December 16, 2010

    Report

    Report Number
    3005099803-2010-05210
    Event Type
    Injury
    Date Received
    December 16, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIAN AGE 54 YEARS (RANGE 48-61). (B)(6) 2008 - (B)(6) 2010. "USE OF FULLY COVERED SELF-EXPANDABLE STENT IN BILIARY COMPLICATIONS AFTER LIVER TRANSPLANTATION: A CASE SERIES". (B)(4) - MEDICAL INTERVENTION REQUIRED. (B)(4) - THE REPORTED ISSUE OF STENT MIGRATED. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THROUGH A REVIEW OF THE ARTICLE "USE OF FULLY COVERED SELF-EXPANDABLE STENT IN BILIARY COMPLICATIONS AFTER LIVER TRANSPLANTATION: A CASE SERIES", BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF A STUDY IN WHICH WALLFLEX BILIARY RX COVERED STENTS WERE IMPLANTED TO TREAT POST TRANSPLANT BILIARY STENOSIS OR LEAKAGE RESULTING FROM DUCT-TO-DUCT ANASTOMOSIS. THE STUDY INVOLVED 11 PATIENTS AND THE STENTS WERE SUCCESSFULLY IMPLANTED BETWEEN (B)(6) 2008 AND (B)(6) 2010. THIS REPORT IS FOR PATIENT # 4. (B)(6) DAYS POST DUCT-TO-DUCT ANASTOMOSIS, PATIENT # 4 PRESENTED WITH BILIARY LEAKAGE. AS A RESULT, THE PATIENT UNDERWENT A PAPILLOTOMY TO PLACE THE WALLFLEX BILIARY RX COVERED STENT. AT AN UNKNOWN DATE THE PATIENT "LOST THE STENT SPONTANEOUSLY". THIS PATIENT MAY HAVE ALSO DEVELOPED MILD BILIARY SEPSIS, BUT THIS COULD NOT BE CONFIRMED. LATER THE PATIENT UNDERWENT A HEPATICOJEJUNOSTOMY. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK475

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention