BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX ESOPHAGEAL NG

    MDR report key: 16709044 · Received April 10, 2023

    Report

    Report Number
    3005099803-2023-01814
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    July 27, 2022
    Report Date
    March 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    UDI-DI
    08714729716150
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(6). IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE PRODUCT INVESTIGATION RESULT OF STENT UNRAVELED. IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE PRODUCT INVESTIGATION RESULT OF STENT DETACHED/SEPARATED. AN ULTRAFLEX ESOPHAGEAL STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. MEDIA INSPECTION WAS PERFORMED BASED ON THE PHOTO PROVIDED BY THE COMPLAINANT AND SHOWED THE SHAFT WAS BENT IN TWO SECTIONS AND THE STENT WAS FULLY DEPLOYED. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT WAS FULLY DEPLOYED AND EXPANDED. THE STENT WIRES WERE UNRAVELED AND BROKEN, AND THE SHAFT WAS BENT. NO OTHER ISSUES WERE NOTED TO THE STENT AND DELIVERY SYSTEM. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED; THE STENT WAS RETURNED FULLY DEPLOYED AND EXPANDED. HOWEVER, THE REPORTED DEVICE MALFUNCTION OF SHAFT BENT WAS CONFIRMED. THE DAMAGES NOTED WERE MOST LIKELY DUE TO PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUES USED BY THE USER, LIMITED THE PERFORMANCE OF THE DEVICE AND COULD HAVE CAUSED KINKING OF THE DELIVERY SHAFT. ADDITIONALLY, HANDLING AND MANIPULATION OF THE STENT DURING REMOVAL COULD HAVE RESULTED TO STENT WIRE BROKE AND UNRAVELED. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 0

    BLOCKS B5 AND H6 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON JANUARY 30, 2024. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK H6: IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE PRODUCT INVESTIGATION RESULT OF STENT UNRAVELED. IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE PRODUCT INVESTIGATION RESULT OF STENT DETACHED/SEPARATED. BLOCK H10: AN ULTRAFLEX ESOPHAGEAL STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. MEDIA INSPECTION WAS PERFORMED BASED ON THE PHOTO PROVIDED BY THE COMPLAINANT AND SHOWED THE SHAFT WAS BENT IN TWO SECTIONS AND THE STENT WAS FULLY DEPLOYED. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT WAS FULLY DEPLOYED AND EXPANDED. THE STENT WIRES WERE UNRAVELED AND BROKEN, AND THE SHAFT WAS BENT. NO OTHER DAMAGES WERE NOTED TO THE STENT AND DELIVERY SYSTEM. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED; THE STENT WAS RETURNED FULLY DEPLOYED AND EXPANDED. HOWEVER, THE REPORTED DEVICE MALFUNCTION OF SHAFT BENT WAS CONFIRMED. THE DAMAGES NOTED WERE MOST LIKELY DUE TO PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUES USED BY THE USER, LIMITED THE PERFORMANCE OF THE DEVICE AND COULD HAVE CAUSED KINKING OF THE DELIVERY SHAFT. ADDITIONALLY, HANDLING AND MANIPULATION OF THE STENT DURING REMOVAL COULD HAVE RESULTED TO STENT WIRE BROKE AND UNRAVELED. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 6CM MALIGNANT ESOPHAGEAL STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AFTER OPENING THE PACKAGE, THE BLACK STENT DEPLOYMENT SUTURE UNRAVELED, AND THE STENT WAS DEPLOYED PARTIALLY. THE PROCEDURE WAS COMPLETED WITH A WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE SHAFT WAS BENT AND THE STENT WAS FULLY DEPLOYED AND EXPANDED. IT IS POSSIBLE THAT THE PHYSICIAN FULLY DEPLOYED THE STENT OUTSIDE THE PATIENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE PRODUCT INVESTIGATION WHICH REVEALED THAT THE STENT WIRE BREAK AND UNRAVEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO TREAT A 6CM MALIGNANT ESOPHAGEAL STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AFTER OPENING THE PACKAGE, THE BLACK STENT DEPLOYMENT SUTURE UNRAVELED, AND THE STENT WAS DEPLOYED PARTIALLY. THE PROCEDURE WAS COMPLETED WITH A WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE SHAFT WAS BENT AND THE STENT WAS FULLY DEPLOYED AND EXPANDED. IT IS POSSIBLE THAT THE PHYSICIAN FULLY DEPLOYED THE STENT OUTSIDE THE PATIENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE PRODUCT INVESTIGATION WHICH REVEALED THAT THE STENT WIRE BREAK AND UNRAVEL. ADDITIONAL INFORMATION RECEIVED ON JANUARY 30, 2024. IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2022, WAS NOT COMPLETED, AND THE WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED DURING A SECOND PROCEDURE PERFORMED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797933 ULTRAFLEX ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC CORPORATION M00513730 0028049366 08714729716150

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male