BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1961333 · Received January 14, 2011

    Report

    Report Number
    3005099803-2011-00043
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K000308
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4) - ELEVATED BILIRUBIN LEVELS; EXTENDED HOSPITALIZATION. (B)(4) - DEVICE ISSUE/FAILURE UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT COVERED BILIARY ENDOPROSTHESIS WAS IMPLANTED INTO THE COMMON BILE DUCT OF A PATIENT DURING AN ERCP ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010, THE PATIENT DEVELOPED JAUNDICE AND BILIRUBIN LEVELS ELEVATED TO 182. ALTHOUGH THE PHYSICIAN IS ALLEGING "STENT FAILURE"; SPECIFIC INFORMATION REGARDING THE ALLEGED MALFUNCTION WAS NOT REPORTED. THE PHYSICIAN COMMENTED THAT THE PATIENT WAS IN TOO POOR OF CONDITION FOR AN ADDITIONAL ERCP, SO THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION. THE PATIENT'S LAST NOTED CONDITION WAS "STABLE". DESPITE MULTIPLE ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN FURTHER CLARIFICATION OF THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT COVERED BILIARY ENDOPROSTHESIS WAS IMPLANTED INTO THE COMMON BILE DUCT OF A PATIENT DURING AN ERCP ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010, THE PATIENT DEVELOPED JAUNDICE AND BILIRUBIN LEVELS ELEVATED TO 182. ALTHOUGH THE PHYSICIAN IS ALLEGING "STENT FAILURE"; SPECIFIC INFORMATION REGARDING THE ALLEGED MALFUNCTION WAS NOT REPORTED. THE PHYSICIAN COMMENTED THAT THE PATIENT WAS IN TOO POOR OF CONDITION FOR AN ADDITIONAL ERCP, SO THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION. THE PATIENT'S LAST NOTED CONDITION WAS 'STABLE'. DESPITE MULTIPLE ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN FURTHER CLARIFICATION OF THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2011: THE COMPLAINANT REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2011. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS ATTRIBUTED TO THE PROGRESSION OF CANCER, NOT THE WALLSTENT DEVICE. THE PHYSICIAN WAS NOT ABLE TO CONFIRM WHETHER OR NOT THE STENT WAS OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965431100 13535834

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization