BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS 6961-6972 INCLUSIVE

    MDR report key: 3682249 · Received March 17, 2014

    Report

    Report Number
    3005099803-2014-01441
    Event Type
    Injury
    Date Received
    March 17, 2014
    Report Date
    February 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT GENDER WAS REPORTED AS 34 MALES AND 34 FEMALES IN THE LITERATURE REVIEW. THE SPECIFIC UPN AND LOT WERE NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THEY WERE WALLSTENT BILIARY STENTS. THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4). RELATES TO THE REPORTED PATIENT EVENTS OF BILE LEAK AND PNEUMOPERITONEMUM. LITERATURE SOURCE: MULTICENTER STUDY ON ENDOSCOPIC ULTRASOUND-GUIDED EXPANDABLE BILIARY METAL STENT PLACEMENT: CHOICE OF ACCESS ROUTE, DIRECTION OF STENT INSERTION, AND DRAINAGE ROUTE THE DEVICE 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

    BOSTON SCIENTIFIC BECOME AWARE OF MULTIPLE EVENTS USING WALLSTENT BILIARY STENTS THROUGH THE ARTICLE ¿MULTICENTER STUDY ON ENDOSCOPIC ULTRASOUND-GUIDED EXPANDABLE BILIARY METAL STENT PLACEMENT: CHOICE OF ACCESS ROUTE, DIRECTION OF STENT INSERTION, AND DRAINAGE ROUTE¿ WRITTEN BY DR. V. DHIR, ET AL. IT IS IMPORTANT TO MENTION THAT BSC WALLSTENT BILIARY STENTS AND COMPETITOR STENTS WERE INCLUDED WITHIN THE ARTICLE. NO SPECIFIC PATIENT INFORMATION, DEVICE INFORMATION OR SPECIFIC EVENT INFORMATION IS AVAILABLE PER THE AUTHOR. THIS REPORT (MDR ID 3005099803-2014-01441) PERTAINS TO THE 13 EVENTS (5 CHOLANGITIS, 4 BILE LEAK, 1 PERFORATION, 1 BLEED AND 2 PNEUMOPERITONEMUM). THE 1 EVENT OF PERFORATION AND DEATH IS REPORTED SEPARATELY UNDER MDR ID 3005099803-2014-01440. SIXTY-EIGHT PATIENTS (34 MALES, 34 FEMALES) WERE ANALYZED, THROUGH A MULTICENTER RETROSPECTIVE ANALYSIS AT FOUR CENTERS (BALDOTA INSTITUTE OF DIGESTIVE SCIENCES, GLOBAL HOSPITAL, MUMBAI, INDIA, UNIVERSITY OF SÃO PAULO, SÃO PAULO, BRAZIL, CEDARS-SINAI MEDICAL CENTER, LOS ANGELES, USA, AND HOSPITAL DE NAVARRA, PAMPLONA, SPAIN). ALL PATIENTS WHO UNDERWENT THE ENDOSCOPIC ULTRASONOGRAPHY-GUIDED BILIARY DRAINAGE (EUS-BD) HAD MALIGNANT OBSTRUCTIVE JAUNDICE FOLLOWING FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). ALL STENTS WERE PLACED THROUGH TRANSHEPATIC OR TRANSDUODENAL ACCESS. REPORTEDLY THERE WERE 14 COMPLICATIONS OUT OF THE 68 PATIENTS. COMPLICATIONS INCLUDED CHOLANGITIS IN FIVE, BILE LEAK IN FOUR, PERFORATIONS IN TWO, PNEUMOBILIA IN TWO, AND BLEEDING IN ONE PATIENT. THREE PATIENTS WITH CHOLANGITIS HAD A PROXIMAL BLOCK. THESE PATIENTS WERE SUCCESSFULLY MANAGED WITH ANTIBIOTICS. THE OTHER TWO PATIENTS WITH CHOLANGITIS HAD PANCREATIC CANCER AND CHOLANGITIS FOLLOWING FAILED ERCP AT THE TIME OF EUS-BD. BOTH PATIENTS HAD SUCCESSFUL EUS-GUIDED STENT PLACEMENT AND SHOWED A >50% DECLINE IN BILIRUBIN LEVELS, BUT DEVELOPED SEPTICEMIC SHOCK AND DIED. TWO OF THESE THREE PATIENTS ALREADY HAD CHOLANGITIS AS A RESULT OF PRIOR ERCP, AND DIED DESPITE SUCCESSFUL STENT PLACEMENT AND A SUBSEQUENT FALL IN BILIRUBIN LEVELS.BOTH THE PERFORATIONS HAPPENED DURING TRANSLUMINAL STENTING. ONE PATIENT HAD A PERFORATION FOLLOWING CHOLEDOCHODUODENOSTOMY FOR PANCREATIC CANCER AND DUODENAL STENOSIS. HE UNDERWENT SUCCESSFUL STENT PLACEMENT, AND RECOVERED WITH CONSERVATIVE MANAGEMENT. THE SECOND PATIENT HAD A PROXIMAL BLOCK AND DEVELOPED PERFORATION DURING HEPATICOGASTROSTOMY. THE PATIENT UNDERWENT EMERGENCY SURGERY BUT COULD NOT BE SAVED (CAPTURED UNDER MDR ID 3005099803-2014-01440). TWO PATIENTS DEVELOPED BILE LEAK FOLLOWING THE PROCEDURE. ALL THESE PATIENTS RECOVERED WITH CONSERVATIVE MANAGEMENT. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE SUCCESS RATES OF THE VARIOUS TECHNIQUES. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THESE EVENTS TO DATE. THERE WERE MULTIPLE PATIENT COMPLICATIONS AND PRODUCT MANUFACTURERS REPORTED IN THIS STUDY, WITH THE LIMITED INFORMATION AVAILABLE, BSC IS UNABLE TO CONCLUDE SPECIFIC PATIENT INFORMATION AND DEVICE INVOLVEMENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156877 WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS 6961-6972 INCLUSIVE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK384

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention