BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890

    MDR report key: 2001266 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00483
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K081733
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) AND A REVIEW OF SIMILAR COMPLAINTS COULD NOT BE PERFORMED AS THE DEVICE LOT NUMBER IS UNKNOWN. AN INTERNAL REVIEW OF THE COMPUTED TOMOGRAPHY IMAGES ASSOCIATED WITH THIS COMPLAINT, CONCLUDED THAT THE STENT LOOKS CLEARLY FRACTURED. A REVIEW OF THE ALLEGED STENT BREAKAGE WAS CARRIED OUT BY THE OPERATIONS QUALITY GROUP AND FAILED TO CONFIRM OR DETERMINE HOW THE STENT COULD HAVE BROKEN AS DESCRIBED IN THE COMPLAINT EVENT INFORMATION. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. RECURRENT OBSTRUCTIVE JAUNDICE, TUMOR INGROWTH THROUGH THE STENT AND STENT OCCLUSION ARE LISTED IN THE DFU FOR THIS PRODUCT AS POTENTIAL COMPLICATIONS RELATED TO THE USE OF THIS DEVICE. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4), NO CODE AVAILABLE (MEDICAL INTERVENTION REQUIRED). (B)(4) RELATES TO (B)(4) FOR THE REPORTED ISSUE OF STENT BLOCKED/OCCLUDED. (B)(4) RELATES TO (B)(4) FOR THE REPORTED ISSUE OF STENT BROKEN. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED WITHIN THE MID BILE DUCT OF A DIABETIC CANCER PATIENT ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6) 2011, THE PATIENT PRESENTED WITH JAUNDICE. AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE WAS PERFORMED, WHERE IT WAS DISCOVERED DURING A COMPUTED TOMOGRAPHY SCAN THAT THE STENT WAS BROKEN IN TWO PIECES. THE STENT WAS BLOCKED WITH TISSUE IN-GROWTH WHERE IT HAD BEEN SEPARATED. AS A RESULT, A PLASTIC DRAINAGE STENT WAS PLACED IN THE LESION, AND THEN A SECOND METAL STENT WAS PLACED WITHIN THE FIRST METAL STENT. THERE WERE NO REPORTED COMPLICATIONS DURING THE STENT PLACEMENT. THE JAUNDICE HAS BEEN RESOLVED, AND THE PATIENT IS IN STABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED WITHIN THE MID BILE DUCT OF A DIABETIC CANCER PATIENT ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6), 2011, THE PATIENT PRESENTED WITH JAUNDICE. AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE WAS PERFORMED, WHERE IT WAS DISCOVERED DURING A COMPUTED TOMOGRAPHY SCAN THAT THE STENT WAS BROKEN IN TWO PIECES. THE STENT WAS BLOCKED WITH TISSUE IN-GROWTH WHERE IT HAD BEEN SEPARATED. AS A RESULT, A PLASTIC DRAINAGE STENT WAS PLACED IN THE LESION, AND THEN A SECOND METAL STENT WAS PLACED WITHIN THE FIRST METAL STENT. THERE WERE NO REPORTED COMPLICATIONS DURING THE STENT PLACEMENT. THE JAUNDICE HAS BEEN RESOLVED, AND THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00580050

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention