BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX? BILIARY

    MDR report key: 3241633 · Received July 22, 2013

    Report

    Report Number
    3005099803-2013-06901
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: BSC AWARE DATE CHANGED TO (B)(4) 2013 FROM (B)(4)2013.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS 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

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2013-06900 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX BILIARY STENT SYSTEMS WERE PLACED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, TWO ADVANIX STENT WERE IMPLANTED IN THE PANCREATIC DUCT AND BILE DUCT FOR RELIEVE OF PANCREATIC CYST ON AN UNKNOWN DATE. THE PATIENT¿S ANATOMY WAS REPORTED AS ABNORMAL DUE TO LIVER TRANSPLANTATION. THE PATIENT UNDERWENT AN ERCP PROCEDURE ON (B)(6) 2013 BECAUSE THE PHYSICIAN SUSPECTED A PERFORATION. IT WAS NOTED THAT BOTH STENTS MIGRATED IN THE DUODENUM AND THAT THERE WAS PERFORATION IN THE DUODENAL WALL ON THE OPPOSITE SIDE OF THE PAPILLA VATERI. THE PHYSICIAN WAS UNABLE TO TELL WHICH OF THE TWO STENTS CAUSED THE PERFORATION WHICH IS 2-3MM WIDE. THE PERFORATION WAS LEFT TO HEAL ITSELF. THE SURGEON REMOVED BOTH STENTS AND PLACED A WALLFLEX FULLY COVERED BILIARY STENT IN THE BILE DUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2013-06900 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX BILIARY STENT SYSTEMS WERE PLACED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREOTOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, TWO ADVANIX STENT WERE IMPLANTED IN THE PANCREATIC DUCT AND BILE DUCT FOR RELIEVE OF PANCREATIC CYST ON AN UNKNOWN DATE. THE PATIENT¿S ANATOMY WAS REPORTED AS ABNORMAL DUE TO LIVER TRANSPLANTATION. THE PATIENT UNDERWENT AN ERCP PROCEDURE ON (B)(6) 2013 BECAUSE THE PHYSICIAN SUSPECTED A PERFORATION. IT WAS NOTED THAT BOTH STENTS MIGRATED IN THE DUODENUM AND THAT THERE WAS PERFORATION IN THE DUODENAL WALL ON THE OPPOSITE SIDE OF THE PAPILLA VATERI. THE PHYSICIAN WAS UNABLE TO TELL WHICH OF THE TWO STENTS CAUSED THE PERFORATION WHICH IS 2-3MM WIDE. THE PERFORATION WAS LEFT TO HEAL ITSELF. THE SURGEON REMOVED BOTH STENTS AND PLACED A WALLFLEX FULLY COVERED BILIARY STENT IN THE BILE DUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340445 ADVANIX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00534220

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention