BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3897186 · Received June 26, 2014

    Report

    Report Number
    3005099803-2014-02321
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE PROXIMAL END OF THE STENT WAS RECEIVED PARTIALLY DEPLOYED BY 18MM. NO ISSUES WERE NOTED WITH THE PROFILE OF THE CROCHET STITCHES ON THE DEVICE. THE OUTER DIAMETER WAS TAKEN AT VARIOUS LOCATIONS ALONG THE LENGTH OF THE CROCHETED STENT AND NO MEASUREMENTS WERE ABOVE 12.5MM, WHICH IS WITHIN SPECIFICATION. DURING ANALYSIS IT WAS POSSIBLE TO FULLY DEPLOY THE STENT WITHOUT ISSUE. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT. THEREFORE, THE NOTED ISSUE WAS 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE STENT WAS USED DURING PLACEMENT OF AN ESOPHAGEAL PROTHESIS PERFORMED ON (B)(6) 2014. THE STENT WAS PLACED TO TREAT A NARROW STENOSIS CAUSED BY A TUMOR. REPORTEDLY, A TUMOR DILATATION WAS DONE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN DILATED THE LESION TO PASS THE DELIVERY SYSTEM OF THE PROSTHESIS; HOWEVER, THE STENT WAS UNABLE TO PASS THE NARROW STENOSIS. ANOTHER ATTEMPT TO DILATE THE LESION WAS DONE BY THE PHYSICIAN AND THE STENT WAS NOW ABLE TO PASS THE NARROW STENOSIS BUT WITH MUCH DIFFICULTY. WHEN THE PHYSICIAN RELEASED THE STENT, ONLY A PART OF THE STENT WAS RELEASED AND COULD NO LONGER PASS ANY FURTHER. THE PHYSICIAN REMOVED THE PARTIALLY DEPLOYED STENT TOGETHER WITH THE DELIVERY SYSTEM AND USED A COMPETITOR'S DEVICE TO COMPLETE THE PROCEDURE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE STENT WAS USED DURING PLACEMENT OF AN ESOPHAGEAL PROTHESIS PERFORMED ON (B)(6) 2014. THE STENT WAS PLACED TO TREAT A NARROW STENOSIS CAUSED BY A TUMOR. REPORTEDLY, A TUMOR DILATATION WAS DONE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN DILATED THE LESION TO PASS THE DELIVERY SYSTEM OF THE PROSTHESIS; HOWEVER, THE STENT WAS UNABLE TO PASS THE NARROW STENOSIS. ANOTHER ATTEMPT TO DILATE THE LESION WAS DONE BY THE PHYSICIAN AND THE STENT WAS NOW ABLE TO PASS THE NARROW STENOSIS BUT WITH MUCH DIFFICULTY. WHEN THE PHYSICIAN RELEASED THE STENT, ONLY A PART OF THE STENT WAS RELEASED AND COULD NO LONGER PASS ANY FURTHER. THE PHYSICIAN REMOVED THE PARTIALLY DEPLOYED STENT TOGETHER WITH THE DELIVERY SYSTEM AND USED A COMPETITOR¿S DEVICE TO COMPLETE THE PROCEDURE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373765 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - MARLBOROUGH M00514250 16043508

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR