BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ ESOPHAGEAL NG

    MDR report key: 2143036 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02249
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE FULLY DEPLOYED STENT WAS RECEIVED FOR ANALYSIS; THE STENT DELIVERY SYSTEM WAS NOT RETURNED. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO ISSUE WITH THE PROFILE OF THE STENT. THE CUSTOMER CONFIRMED THAT THE CORRECT DEVICE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MET ITS 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 PERFORMANCE OF THE DEVICE WAS LIMITED LIKELY DUE ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 COVERED ESOPHAGEAL STENT WAS USED DURING AN ESOPHAGEAL STENTING PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE MID-ESOPHAGUS DUE TO A MALIGNANCY. THE STRICTURE WAS 8CM IN LENGTH. THE ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS INSERTED INTO THE ESOPHAGUS AND THE PHYSICIAN BEGAN DEPLOYMENT OF THE STENT. HOWEVER, AS THE PHYSICIAN WAS WITHDRAWING THE DEPLOYMENT SUTURE, RESISTANCE WAS ENCOUNTERED AND THE SUTURE WAS DIFFICULT TO PULL. WHEN THE STENT WAS PARTIALLY DEPLOYED, THE PHYSICIAN WAS UNABLE TO RELEASE THE REMAINING PORTION OF THE SUTURE AND THE STENT FAILED TO COMPLETELY DEPLOY. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. NO VISIBLE ISSUES WERE NOTED WITH THE DEVICE AND THE DEPLOYMENT SUTURE DID NOT APPEAR TO BE CAUGHT OR KNOTTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX COVERED ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT 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 COVERED ESOPHAGEAL STENT WAS USED DURING AN ESOPHAGEAL STENTING PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE MID-ESOPHAGUS DUE TO A MALIGNANCY. THE STRICTURE WAS 8CM IN LENGTH. THE ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT SYSTEM WAS INSERTED INTO THE ESOPHAGUS AND THE PHYSICIAN BEGAN DEPLOYMENT OF THE STENT. HOWEVER, AS THE PHYSICIAN WAS WITHDRAWING THE DEPLOYMENT SUTURE, RESISTANCE WAS ENCOUNTERED AND THE SUTURE WAS DIFFICULT TO PULL. WHEN THE STENT WAS PARTIALLY DEPLOYED, THE PHYSICIAN WAS UNABLE TO RELEASE THE REMAINING PORTION OF THE SUTURE AND THE STENT FAILED TO COMPLETELY DEPLOY. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. NO VISIBLE ISSUES WERE NOTED WITH THE DEVICE AND THE DEPLOYMENT SUTURE DID NOT APPEAR TO BE CAUGHT OR KNOTTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX COVERED ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX¿ ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513750 0013402611

    Patients

    Seq Age Sex Outcome Treatment
    1