BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT¿ RX BILIARY

    MDR report key: 2143163 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02290
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    September 21, 2010
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE WAS REPORTED TO BE EITHER (B)(6), 2011. ATTEMPTS TO CONFIRM THE CORRECT EVENT DATE HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD THE CORRECT EVENT DATE BE CONFIRMED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DEVICE COMPONENT RELATES TO THE DEVICE PROBLEM CODE 3009 FOR THE REPORTED EVENT OF STENT POSITIONING ISSUE. STUDY SOURCE: (B)(6) TRIAL 2009: STEEL (WALLSTENT) VS NITINOL (WALLFLEX). INVESTIGATION: (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(6) 2010.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2011-02290 AND MFR. REPORT #3005099803-2011-02291). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLSTENT BILIARY ENDOPROSTHESES WERE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2010 AS PART OF A POST MARKET STUDY. THE NAME AND COORDINATOR OF THE STUDY WERE NOT PROVIDED. DURING (B)(6) 2011, THE PATIENT RETURNED FOR A SECOND ERCP PROCEDURE. DURING THIS PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD CHOLANGITIS AND JAUNDICE. A PLASTIC ADVANIX BILIARY STENT WAS PLACED AND THE EVENT WAS RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE STENT PLACEMENT PROCEDURE WAS PART OF THE (B)(6) TRIAL 2009: STEEL (WALLSTENT) VS NITINOL (WALLFLEX). THE INVESTIGATOR WAS (B)(6). THE PATIENT HAD A BILIARY STRICTURE DUE TO A PANCREATIC TUMOR. THE STRICTURE WAS 2CM IN LENGTH AND THE DISTANCE FROM THE PROXIMAL END OF THE STRICTURE TO THE BILIARY CONFLUENCE WAS 8CM. THE PHYSICIAN INTENDED TO PLACE ONLY ONE WALLSTENT BILIARY ENDOPROSTHESIS. THE PHYSICIAN PLACED THE FIRST WALLSTENT BILIARY ENDOPROSTHESIS (THE SUBJECT OF MFR REPORT #3005099803-2011-02290); HOWEVER, THE STENT WAS PLACED TOO PROXIMAL. THEREFORE, THE PHYSICIAN PLACED THE SECOND WALLSTENT BILIARY ENDOPROSTHESIS (THE SUBJECT OF MFR REPORT #3005099803-2011-02291) WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS DURING THE INITIAL STENT PLACEMENT PROCEDURE. THE CURRENT PATIENT CONDITION WAS REPORTED TO BE "STABLE" AND THE PATIENT IS AT HOME.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2011-02290 AND MFR. REPORT #3005099803-2011-02291). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLSTENT BILIARY ENDOPROSTHESES WERE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2010 AS PART OF A POST MARKET STUDY. THE NAME AND COORDINATOR OF THE STUDY WERE NOT PROVIDED. DURING (B)(6) 2011, THE PATIENT RETURNED FOR A SECOND ERCP PROCEDURE. DURING THIS PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD CHOLANGITIS AND JAUNDICE. A PLASTIC ADVANIX BILIARY STENT WAS PLACED AND THE EVENT WAS RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2011-02290 AND MFR REPORT #3005099803-2011-02291). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLSTENT BILIARY ENDOPROSTHESES WERE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2010 AS PART OF A POST MARKET STUDY. THE NAME AND COORDINATOR OF THE STUDY WERE NOT PROVIDED. DURING (B)(6) 2011, THE PATIENT RETURNED FOR A SECOND ERCP PROCEDURE. DURING THIS PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD CHOLANGITIS AND JAUNDICE. A PLASTIC ADVANIX BILIARY STENT WAS PLACED AND THE EVENT WAS RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2011: ACCORDING TO THE COMPLAINANT, THE STENT PLACEMENT PROCEDURE WAS PART OF THE (B)(4): STEEL (WALLSTENT) VS NITINOL (WALLFLEX). THE INVESTIGATOR WAS (B)(4). THE PATIENT HAD A BILIARY STRICTURE DUE TO A PANCREATIC TUMOR. THE STRICTURE WAS 2CM IN LENGTH AND THE DISTANCE FROM THE PROXIMAL END OF THE STRICTURE TO THE BILIARY CONFLUENCE WAS 8CM. THE PHYSICIAN INTENDED TO PLACE ONLY ONE WALLSTENT BILIARY ENDOPROSTHESIS. THE PHYSICIAN PLACED THE FIRST WALLSTENT BILIARY ENDOPROSTHESIS (THE SUBJECT OF MFR REPORT #3005099803-2011-02290); HOWEVER, THE STENT WAS PLACED TOO PROXIMAL. THEREFORE, THE PHYSICIAN PLACED THE SECOND WALLSTENT BILIARY ENDOPROSTHESIS (THE SUBJECT OF MFR REPORT #3005099803-2011-02291) WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS DURING THE INITIAL STENT PLACEMENT PROCEDURE. THE CURRENT PATIENT CONDITION WAS REPORTED TO BE "STABLE" AND THE PATIENT IS AT HOME. **ADDITIONAL INFORMATION RECEIVED SINCE SEPTEMBER 2, 2011** THE SECOND ERCP PROCEDURE, WHEN IT WAS DISCOVERED THAT THE PATIENT HAD CHOLANGITIS AND JAUNDICE, WAS PERFORMED ON MAY 26, 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT¿ RX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00569700 12583227

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention