BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? ESOPHAGEAL

    MDR report key: 3151512 · Received June 7, 2013

    Report

    Report Number
    3005099803-2013-04603
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K073266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE EVALUATION FINDINGS OF STENT DEPLOYMENT ISSUE (PARTIAL DEPLOYMENT). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY 85 MM. IT WAS NOTED THAT THE STENT HAD BEEN MOVED DISTALLY OFF THE DISTAL END OF THE SHAFT SO IT WAS LOCATED APPROXIMATELY 60 MM DISTAL TO THE DISTAL END OF THE TIP. THE CATHETER WAS KINKED AT APPROXIMATELY 250 MM PROXIMAL TO THE DISTAL TIP. THE SHAFT WAS KINKED AT APPROXIMATELY 250 MM DISTAL TO THE DISTAL END OF THE HANDLE. DURING ANALYSIS, IT WAS POSSIBLE TO FULLY DEPLOY THE STENT WITHOUT ISSUE. THERE WAS NO ISSUE IN THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. THE INNER SHAFT WAS KINKED AT 245 MM PROXIMAL TO THE DISTAL TIP. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 REVEALED THAT NO SIMILAR 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. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT SYSTEM WAS USED DURING A STENT IMPLANTATION PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR ESOPHAGEAL CANCER. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, WHEN ATTEMPTING TO DEPLOY THE STENT, THE SHAFT BENT AND THE STENT COULD NOT BE FULLY DEPLOYED. THE STENT WAS FULLY RECONSTRAINED AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. BASED ON THE DEVICE ANALYSIS, WHICH INDICATES THAT THE STENT WAS RECEIVED PARTIALLY DEPLOYED, THIS IS NOW CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252785 WALLFLEX? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516920 0015396597

    Patients

    Seq Age Sex Outcome Treatment
    1