BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3964828 · Received July 29, 2014

    Report

    Report Number
    3005099803-2014-02652
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT APPROXIMATELY 20MM OF THE STENT WAS PARTIALLY DEPLOYED WHEN RECEIVED. THE DEPLOYMENT SUTURE WAS BROKEN AT 740MM FROM ITS POINT OF RELEASE FROM THE STENT, WAS FRAYED IN APPEARANCE AND TIED AROUND THE DEVICE SHAFT. A SECTION OF THE DEPLOYMENT SUTURE MEASURING 350 MM WAS WHITENED IN APPEARANCE. DURING ANALYSIS A RESTRICTION WAS MET WHEN ATTEMPTING TO RETRACT THE DEPLOYMENT SUTURE BECAUSE IT WAS ENTANGLED. BENDS WERE NOTED IN THE SHAFT. SINCE THE STENT HAD BEEN ABLE TO PARTIALLY DEPLOY, IT WAS DETERMINED THAT THE ENTANGLEMENT OF THE DEPLOYMENT SUTURE HAD LIKELY OCCURRED POST BREAKAGE OF THE DEPLOYMENT SUTURE. DURING ANALYSIS THE DEPLOYMENT SUTURE WAS UNTANGLED AND IT WAS POSSIBLE TO FULLY DEPLOY THE STENT WITHOUT ISSUE BUT THE STENT DID NOT FULLY EXPAND. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE NOTED ISSUES WERE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF STENT DEPLOYMENT SUTURE BROKEN. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT WAS USED IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. THIS WAS TO TREAT AN INFILTRATIVE LESION INVOLVING THE PROXIMAL THIRD OF THE ANTRUM, GASTRIC BODY AND GASTRIC FUNDUS INVADING THE CARDIA DUE TO PLASTIC LINITIS. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, HOWEVER, THE DEPLOYMENT SUTURE BROKE. THE STENT WAS REMOVED FROM THE PATIENT FULLY CONSTRAINED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT WAS USED IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. THIS WAS TO TREAT AN INFILTRATIVE LESION INVOLVING THE PROXIMAL THIRD OF THE ANTRUM, GASTRIC BODY AND GASTRIC FUNDUS INVADING THE CARDIA DUE TO PLASTIC LINITIS. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, HOWEVER, THE DEPLOYMENT SUTURE BROKE. THE STENT WAS REMOVED FROM THE PATIENT FULLY CONSTRAINED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT. 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
    441600 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513730 0016726433

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR