BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 1930741 · Received December 16, 2010

    Report

    Report Number
    3005099803-2010-05214
    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). "USE OF FULLY COVERED SELF-EXPANDABLE STENT IN BILIARY COMPLICATIONS AFTER LIVER TRANSPLANTATION: A CASE SERIES". (B)(4) - PANCREATITIS; 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 # 9. AT (B)(6) DAYS POST DUCT-TO-DUCT ANASTOMOSIS, PATIENT # 9 PRESENTED WITH BILIARY STENOSIS. AS A RESULT, A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED. AT AN UNKNOWN DATE THE PATIENT "LOST THE STENT SPONTANEOUSLY". THIS PATIENT DEVELOPED PANCREATITIS AND IS CURRENTLY WAITING ON A HEPATICOJEJUNOSTOMY. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE 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