BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE

    MDR report key: 1934194 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05233
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MEDICAL INTERVENTION REQUIRED; HOSPITALIZED. (B)(4) - THE REPORTED ISSUE OF CATHETER DIFFICULT TO REMOVE. (B)(4) - THE REPORTED ISSUE OF STENT EXPANSION ISSUES. THE COMPLAINT INDICATED THAT THE STENT HAS BEEN IMPLANTED; HOWEVER, THE DELIVERY SYSTEM HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE STENT HAD BEEN DEPLOYED FROM THE DEVICE AND HAD NOT BEEN RETURNED. A VISUAL EXAMINATION OF THE RETURNED DELIVERY SYSTEM FOUND THAT THE DEVICE WAS RETURNED IN THREE SECTIONS. THE BLUE OUTER SHEATH WAS DETACHED, DISTAL TO THE DISTAL END OF THE DISTAL HANDLE AND THE INNER SHEATH WAS ALSO DETACHED, DISTAL TO THE DISTAL END OF THE HUB. THE CLEAR OUTER SHEATH AND THE BLUE OUTER SHEATH WERE KINKED AT VARIOUS LOCATIONS ALONG THE LENGTH OF THE DISTAL DETACHED SECTION OF THE DEVICE. THE INNER HAD BEEN REMOVED FROM THE DEVICE AND WAS SEVERELY KINKED AND TWISTED FROM THE SCIVED AREA OF THE INNER LUMEN TO THE DISTAL TIP. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT RX BILIARY ENDOPROSTHESES WAS IMPLANTED WITHIN THE LEFT HEPATIC DUCT OF A PATIENT WITH PANCREATIC CANCER ON (B)(6) 2010. ACCORDING TO THE COMPLAINT, THE PATIENT ALSO SUFFERED FROM METASTATIC LIVER DISEASE AND OBSTRUCTIVE JAUNDICE. AFTER THE STENT WAS DEPLOYED WITHIN THE PATIENT'S UPPER LEFT HEPATIC DUCT; THE PHYSICIAN WAS UNABLE TO PULL THE DELIVERY SYSTEM THROUGH THE STENT SO THAT IT COULD BE REMOVED. THE DOCTOR ATTEMPTED UNSUCCESSFULLY TO RE-SHEATH THE CATHETER AND REMOVE THE DELIVERY SYSTEM. THE PHYSICIAN ATTEMPTED TO CUT THE CATHETER IN HALF AT THE PAPILLA OF THE COMMON BILE DUCT USING ENDOSCOPIC SCISSORS, BUT WAS UNSUCCESSFUL. THE DOCTOR THEN ATTEMPTED TO BURN THE CATHETER IN HALF AT THE PAPILLA USING CAUTERY, BUT WAS AGAIN UNSUCCESSFUL. THE DOCTOR CUT THE DELIVERY CATHETER AT THE BIOPSY CAP OF THE ERCP SCOPE USING WIRE CUTTERS. THE OLYMPUS 160 ERCP SCOPE WAS REMOVED FROM THE PATIENT LEAVING THE DELIVERY CATHETER WITHIN THE PATIENT. THE END OF THE CATHETER WAS TAPED TO THE PATIENT'S FACE WITH THE REMAINDER OF THE CATHETER WITHIN THE PATIENT THROUGH THE DUODENUM AND INTO THE COMMON BILE DUCT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION, AND IS CURRENTLY IN THE INTENSIVE CARE UNIT THE PHYSICIAN PLANNED TO VIEW THE PATIENT'S BILIARY ANATOMY UNDER FLUOROSCOPY THE FOLLOWING DAY, TO SEE IF THE STENT HAS EXPANDED SUFFICIENTLY TO REMOVE THE DELIVERY SYSTEM. IF THE STENT WAS FULLY EXPANDED, ANOTHER ATTEMPT WILL BE MADE TO REMOVE THE DELIVERY SYSTEM ENDOSCOPICALLY. IF THEY ARE UNABLE TO REMOVE THE DELIVERY SYSTEM ENDOSCOPICALLY THEY WILL ATTEMPT TO OPEN THE STENT FROM ABOVE, WHERE THE CATHETER IS STUCK, BY PERFORMING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM. TO DATE, DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO GATHER ANY ADDITIONAL EVENT/PATIENT INFORMATION FROM THE COMPLAINANT. 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 RX BILIARY ENDOPROSTHESES WAS IMPLANTED WITHIN THE LEFT HEPATIC DUCT OF A PATIENT WITH PANCREATIC CANCER ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, THE PATIENT ALSO SUFFERED FROM METASTATIC LIVER DISEASE AND OBSTRUCTIVE JAUNDICE. AFTER THE STENT WAS DEPLOYED WITHIN THE PATIENT'S UPPER LEFT HEPATIC DUCT; THE PHYSICIAN WAS UNABLE TO PULL THE DELIVERY SYSTEM THROUGH THE STENT SO THAT IT COULD BE REMOVED. THE DOCTOR ATTEMPTED UNSUCCESSFULLY TO RE-SHEATH THE CATHETER AND REMOVE THE DELIVERY SYSTEM. THE PHYSICIAN ATTEMPTED TO CUT THE CATHETER IN HALF AT THE PAPILLA OF THE COMMON BILE DUCT USING ENDOSCOPIC SCISSORS, BUT WAS UNSUCCESSFUL. THE DOCTOR THEN ATTEMPTED TO BURN THE CATHETER IN HALF AT THE PAPILLA USING CAUTERY, BUT WAS AGAIN UNSUCCESSFUL. THE DOCTOR CUT THE DELIVERY CATHETER AT THE BIOPSY CAP OF THE ERCP SCOPE USING WIRE CUTTERS. THE OLYMPUS 160 ERCP SCOPE WAS REMOVED FROM THE PATIENT LEAVING THE DELIVERY CATHETER WITHIN THE PATIENT. THE END OF THE CATHETER WAS TAPED TO THE PATIENT'S FACE WITH THE REMAINDER OF THE CATHETER WITHIN THE PATIENT THROUGH THE DUODENUM AND INTO THE COMMON BILE DUCT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION, AND IS CURRENTLY IN THE INTENSIVE CARE UNIT THE PHYSICIAN PLANNED TO VIEW THE PATIENT'S BILIARY ANATOMY UNDER FLUOROSCOPY THE FOLLOWING DAY, TO SEE IF THE STENT HAS EXPANDED SUFFICIENTLY TO REMOVE THE DELIVERY SYSTEM. IF THE STENT WAS FULLY EXPANDED, ANOTHER ATTEMPT WILL BE MADE TO REMOVE THE DELIVERY SYSTEM ENDOSCOPICALLY. IF THEY ARE UNABLE TO REMOVE THE DELIVERY SYSTEM ENDOSCOPICALLY THEY WILL ATTEMPT TO OPEN THE STENT FROM ABOVE, WHERE THE CATHETER IS STUCK, BY PERFORMING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM. TO DATE, DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO GATHER ANY ADDITIONAL EVENT/PATIENT INFORMATION FROM THE COMPLAINANT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00569640 0013312097

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R OLYMPUS 160 ERCP SCOPE