WALLFLEX BILIARY

Additional Manufacturer Narrative

BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN JANUARY 1, 2010 AND JANUARY 1, 2023. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE UPN AND LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER CITY: (B)(6). BLOCK G2: LITERATURE SOURCE: THOMAS GUILMOTEAU, ET AL. DIRECT COMPARISON OF SIMULTANEOUS AND SEQUENTIAL ENDOSCOPIC METALLIC BILATERAL STENTING IN MALIGNANT HILAR BILIARY OBSTRUCTION. WORLD J GASTROENTEROL 2025 MAY 21; 31(19): 101913. DOI: 10.3748/WJG. V31.I19.101913. BLOCK H6: IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

Description of Event or Problem

BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A WALLFLEX BILIARY STENTS THROUGH THE ARTICLE "DIRECT COMPARISON OF SIMULTANEOUS AND SEQUENTIAL ENDOSCOPIC METALLIC BILATERAL STENTING IN MALIGNANT HILAR BILIARY OBSTRUCTION" BY THOMAS GUILMOTEAU, ET AL. THIS RETROSPECTIVE STUDY FOCUSED ON THE DIFFERENT DRAINAGE TECHNIQUES USING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR MALIGNANT HILAR BILIARY OBSTRUCTION. ALL PATIENTS WHO UNDERWENT BILATERAL BILIARY METALLIC STENTING DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR MHBO IN CLERMONT-FERRAND UNIVERSITY HOSPITAL BETWEEN JANUARY 1, 2010 AND JANUARY 1, 2023. CONVENTIONAL SEQUENTIAL SBS PLACEMENT WAS PERFORMED AT OUR INSTITUTION BETWEEN 2010 AND 2017. SINCE 2017, SIMULTANEOUS SBS PLACEMENT HAS BEEN PERFORMED ON PATIENTS WITH UNRESECTABLE MHBOS REQUIRING BILATERAL DRAINAGE. THE PATIENT COHORT WAS DIVIDED INTO THOSE WHO UNDERWENT SEQUENTIAL SBS OR SIS PLACEMENT BETWEEN 2010 AND 2017 (SEQUENTIAL GROUP) AND THOSE WHO UNDERWENT SIMULTANEOUS SBS PLACEMENT BETWEEN 2017 AND 2023 (SIMULTANEOUS GROUP). THE TWO GROUPS WERE COMPARED RETROSPECTIVELY. THE ARTICLE REPORTED PROCEDURAL DETAILS AND OUTCOMES FOLLOWING THE SEQUENTIAL SBS TECHNIQUE. ADVERSE EVENTS INCLUDED CHOLANGITIS WITH MULTIVISCERAL FAILURE PROGRESSING TO SEPTIC SHOCK, WHICH RESULTED IN DEATH. PLEASE REFER TO THE REFERENCED ARTICLE FOR FULL DETAILS, DATA ANALYSIS, AND LIST OF PARTICIPATING INVESTIGATORS AND INSTITUTIONS.

Description of Event or Problem

BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A WALLFLEX BILIARY STENTS THROUGH THE ARTICLE "DIRECT COMPARISON OF SIMULTANEOUS AND SEQUENTIAL ENDOSCOPIC METALLIC BILATERAL STENTING IN MALIGNANT HILAR BILIARY OBSTRUCTION" BY THOMAS GUILMOTEAU, ET AL.THIS RETROSPECTIVE STUDY FOCUSED ON THE DIFFERENT DRAINAGE TECHNIQUES USING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR MALIGNANT HILAR BILIARY OBSTRUCTION. ALL PATIENTS WHO UNDERWENT BILATERAL BILIARY METALLIC STENTING DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR MHBO IN (b)(6) HOSPITAL BETWEEN (b)(6) 2010 AND (b)(6),2023. CONVENTIONAL SEQUENTIAL SBS PLACEMENT WAS PERFORMED AT OUR INSTITUTION BETWEEN 2010 AND 2017. SINCE 2017, SIMULTANEOUS SBS PLACEMENT HAS BEEN PERFORMED ON PATIENTS WITH UNRESECTABLE MHBOS REQUIRING BILATERAL DRAINAGE. THE PATIENT COHORT WAS DIVIDED INTO THOSE WHO UNDERWENT SEQUENTIAL SBS OR SIS PLACEMENT BETWEEN 2010 AND 2017 (SEQUENTIAL GROUP) AND THOSE WHO UNDERWENT SIMULTANEOUS SBS PLACEMENT BETWEEN 2017 AND 2023 (SIMULTANEOUS GROUP). THE TWO GROUPS WERE COMPARED RETROSPECTIVELY. THE ARTICLE REPORTED PROCEDURAL DETAILS AND OUTCOMES FOLLOWING THE SEQUENTIAL SBS TECHNIQUE. ADVERSE EVENTS INCLUDED CHOLANGITIS WITH MULTIVISCERAL FAILURE PROGRESSING TO SEPTIC SHOCK, WHICH RESULTED IN DEATH.PLEASE REFER TO THE REFERENCED ARTICLE FOR FULL DETAILS, DATA ANALYSIS, AND LIST OF PARTICIPATING INVESTIGATORS AND INSTITUTIONS.

Additional Manufacturer Narrative

BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN JANUARY 1, 2010 AND JANUARY 1, 2023.BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE UPN AND LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.BLOCK E1:INITIAL REPORTER CITY: CLERMONT-FERRAND, AUVERGNE-RHONE-ALPES; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD.BLOCK G2: LITERATURE SOURCE: THOMAS GUILMOTEAU, ET AL. DIRECT COMPARISON OF SIMULTANEOUS AND SEQUENTIAL ENDOSCOPIC METALLIC BILATERAL STENTING IN MALIGNANT HILAR BILIARY OBSTRUCTION. WORLD J GASTROENTEROL 2025 MAY 21; 31(19): 101913. DOI: 10.3748/WJG. V31.I19.101913BLOCK H6:IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITISIMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF SEPSISIMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATHBLOCK H11:INVESTIGATION RESULTS:BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENTS OF DEATH, SEPTIC SHOCK, CHOLANGITIS, AND MULTIPLE ORGAN FAILURE. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. HOWEVER, MEDIA INSPECTION OF THE ATTACHED DOCUMENTATION SHOWS THE DIFFERENT MECHANISMS INSIDE THE PATIENT'S ANATOMY. CHOLANGITIS, AND DEATH IS ALSO NOTED WITHIN THE INSTRUCTIONS FOR USE (IFU) AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. DEVICE TECHNICAL ANALYSIS: THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. HOWEVER, MEDIA INSPECTION OF THE ATTACHED DOCUMENTATION SHOWS THE DIFFERENT MECHANISMS INSIDE THE PATIENT'S ANATOMY.LABELING REVIEW:A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/ PRODUCT LABEL. ADDITIONALLY, CHOLANGITIS, AND DEATH ARE NOTED WITHIN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE ADVERSE EVENTS RELATED TO THE USE OF THE DEVICE.RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE REPORTED EVENTS OF DEATH, SEPTIC SHOCK, CHOLANGITIS, MULTIPLE ORGAN FAILURE AND INTENSIVE CARE WAS DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION:BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF NO PROBLEM DETECTED.